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CTRI Number

CTRI/2025/06/088588 [Registered on: 11/06/2025] Trial Registered Prospectively

Last Modified On:

11/06/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A phase 2 double-blind study of Toriplaimab with chemotherapy vs placebo with chemotherapy in patients diagnosed with HER2-negative, untreated, advanced or metastatic stomach or stomach-foodpipe junction cancer to prevent cancer from getting worse and live longer for at least 12 months

Scientific Title of Study

Phase 2, randomized, investigator initiated clinical study of Toripalimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Trial Acronym

Torch-GO

Secondary IDs if Any

Secondary ID	Identifier
Project No 4731 Version 2.0_11APR2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vikas Ostwal
Designation	Professor and Head GI Medical Oncology Unit
Affiliation	Tata Memorial Hospital
Address	Room No 1102, Homi Bhabha Building,Dept of Medical Oncology, Gastrointestinal Disease Management Group, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Phone	9702288801
Fax
Email	dr.vikas.ostwal@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vikas Ostwal
Designation	Professor and Head GI Medical Oncology Unit
Affiliation	Tata Memorial Hospital
Address	Room No 1102, Homi Bhabha Building,Dept of Medical Oncology, Gastrointestinal Disease Management Group, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Phone	9702288801
Fax
Email	dr.vikas.ostwal@gmail.com

Details of Contact Person
Public Query

Name	Dr Vikas Ostwal
Designation	Professor and Head GI Medical Oncology Unit
Affiliation	Tata Memorial Hospital
Address	Room No 1102, Homi Bhabha Building,Dept of Medical Oncology, Gastrointestinal Disease Management Group, Parel, Mumbai Mumbai MAHARASHTRA 400012 India
Phone	9702288801
Fax
Email	dr.vikas.ostwal@gmail.com

Source of Monetary or Material Support

Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai,Maharashtra, India 400012

Primary Sponsor

Name	Tata Memorial Hospital
Address	TMC Research Administration Council, Main Buidling 3rd Floor, Dr E Borges Road, Parel, Mumbai, Maharashtra, India-400012
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vikas Ostwal	Tata Memorial Hospital, Mumbai	Room No 319, Dpet of Medical Oncology, Gastrointestinal Disease management Group, 3rd Floor, Homi Bhabha Building,Dr E Borges Road, Parel, Mumbai MAHARASHTRA	9702288801 dr.vikas.ostwal@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Tata Memorial Hospital Institutional Ethics Committee-I	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C155\|\|Malignant neoplasm of lower thirdof esophagus, (2) ICD-10 Condition: C169\|\|Malignant neoplasm of stomach, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Arm A: Toripalimab Plus CAPOX	A)Toripalimab: Dosage: 240 mg administered intravenously on Day 1 of each treatment cycle. Frequency: Every 3 weeks (Q3W). B)CAPOX Chemotherapy: 1.Oxaliplatin: Dosage: 130 mg/m² administered intravenously on Day 1 of each cycle. 2.Capecitabine: Dosage: 1000 mg/m² taken orally twice daily on Days 1 to 14 of each cycle. Frequency: Chemotherapy is given every 3 weeks.
Comparator Agent	Arm B: Placebo Plus CAPOX	A) Placebo-Placebo will be administered intravenously on Day 1 of each treatment cycle, matching the schedule for Toripalimab. Frequency: Every 3 weeks (Q3W). B) CAPOX Chemotherapy: 1.Oxaliplatin: Dosage: 130 mg/m² administered intravenously on Day 1 of each cycle. 2.Capecitabine: Dosage: 1000 mg/m² taken orally twice daily on Days 1 to 14 of each cycle. Frequency: Chemotherapy is given every 3 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	1.Participants must be male or female and at least 18 years old when they provide documented informed consent. 2. Participants must have a histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, with known PD-L1 expression status. 3. PD-L1 CPS equal to or more than 10 and or MSI-H 4.Participants must have HER2 negative cancer, defined as IHC score of 0 or positive 1) or FISH negative (HER2 ratio less than 2 with an average HER2 copy number less than 4.0 signals per cell). Locally available ISH methods may be used as per institutional guidelines. 5. Male participants must agree to refrain from donating sperm and either remain abstinent or use contraception during the study and for at least 95 days after the last dose of chemotherapy. 6. Female participants must not be pregnant or breastfeeding and must agree to use effective contraception if of childbearing potential (WOCBP), with pregnancy testing required before study participation. 7. Participants must provide written informed consent for the study, with optional consent for future biomedical research. 8. Participants must have measurable disease per RECIST 1.1 criteria as assessed by the investigator. 9. Participants must have an ECOG performance status of 0 or 1 within 3 days before starting the study intervention. 10. Participants must have adequate organ function as defined by study-specific laboratory criteria

ExclusionCriteria

Details

1. Participants with squamous cell or undifferentiated gastric cancer.
2. Participants who have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or who anticipate needing major surgery during the study. Participants must have recovered adequately from prior surgery.
3. Participants with preexisting peripheral neuropathy greater than Grade 1.
4. Women of childbearing potential (WOCBP) with a positive pregnancy test within 72 hours prior to randomization.
5. Participants with prior therapy for locally advanced, unresectable, or metastatic gastric/GEJ cancer, unless neoadjuvant/adjuvant therapy was completed at least 6 months before randomization.
6. Participants with prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy, or other T-cell receptor-targeting therapies (e.g., CTLA-4, OX-40, CD137).
7. Participants able to afford immune checkpoint inhibitors (ICIs) such as PD-1 inhibitors (Nivolumab, Pembrolizumab, and Cemiplimab), PDL-1 inhibitors (Atezolimumab, Durvalumab and Avelumab), and CTLA-4 inhibitors (Ipilimumab) as a standard of care will be excluded from the study.
8. Participants with prior systemic anticancer therapy within 4 weeks before randomization
9. Participants with prior radiotherapy within 2 weeks before starting the study, unless it was used for palliative radiation to non-CNS disease.
10. Participants who have received a live or live-attenuated vaccine within 30 days before the first dose.
11. Participants currently in or recently participated in an interventional clinical study within 4 weeks prior to the first dose.
12. Participants with immunodeficiency or those receiving chronic systemic steroids (dose more than 10 mg prednisone equivalent) or immunosuppressive therapy within 7 days before the first dose.
13. Participants with a progressing malignancy or requiring active treatment within the past 5 years (except certain skin carcinomas or carcinoma in situ).
14. Participants with known active CNS metastases or carcinomatous meningitis, unless previously treated and stable without steroids for at least 14 days.
15. Participants with severe hypersensitivity (equal to or more than Grade 3) to Toripalimab or its excipients.
16. Participants with active autoimmune disease requiring systemic treatment in the past 2 years (except replacement therapy).
17. Participants with a history of (non-infectious) pneumonitis requiring steroids or current pneumonitis.
18. Participants with active infection requiring systemic therapy.
19. Participants with a known history of HIV infection.
20. Participants with a known history of active and uncontrolled Hepatitis B or C infection.
21. Participants with a history of active tuberculosis.
22. Participants with any condition or laboratory abnormality that might interfere with study results or participation.
23. Participants with a psychiatric or substance abuse disorder that would interfere with study requirements.
24. Pregnant or breastfeeding participants, or those expecting to conceive or father children during the study and follow-up period.
25. Participants with a history of allogenic tissue/solid organ transplant.
26. Participants with severe hypersensitivity (more than or equal to Grade 3) to study chemotherapy agents or excipients.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Progression-free survival (PFS)	the time from the time of diagnosis of an advanced disease to the time of disease progression or loss to follow-up or death, whichever is earlier or at the end of 12 Months

Secondary Outcome

Outcome	TimePoints
Overall survival (OS)	defined as the time from the time of diagnosis to the time of death, lost to follow-up or last observation at the end of 12 Months
Objective response (OR)	evaluated as per RECIST criteria at 6 months from the date of randomisation
side effects and adverse event profile with the combination	meausered at the end of trial
quality of life assessment	at baseline and every two month till study participation

Target Sample Size

Total Sample Size="190"
Sample Size from India="190"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

30/06/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Title:- Phase 2, randomized, investigator-initiated clinical study of Toripalimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (TORCH-GO)

Principle Investigator - Dr Vikas S Ostwal:

Study Site- Tata Memorial Centre, Mumbai

Summary

The TORCH-GO study is a Phase 2, randomized, investigator-initiated, non-comparative clinical trial investigating the efficacy of Toripalimab combined with chemotherapy versus a placebo with chemotherapy as a first-line treatment for previously untreated HER2 negative, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma.

The rationale for the study is supported by evidence showing improved outcomes in advanced cancers treated with immune checkpoint inhibitors like Toripalimab. The trial targets PD-L1 positive patients (CPS equal to or more than 10) and those with microsatellite instability-high (MSI-H) tumour status, hypothesizing that these groups are likely to benefit the most from the combination therapy.

The primary aim of the TORCH-GO study is to assess the efficacy of Toripalimab and chemotherapy versus a placebo combined with chemotherapy in terms of progression-free survival in patients with previously untreated HER2 negative, unresectable, or metastatic gastric or GEJ adenocarcinoma.

Inclusion criteria focus on participants with confirmed diagnoses, PD-L1 expression, HER2 negative status, and specific age and performance status benchmarks, while exclusion criteria highlight recent treatments, specific health conditions, and pregnancy

Inclusion Criteria: Participants must have a confirmed diagnosis of locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma, PD-L1 CPS more than or equal to 10, HER2 negative status, an ECOG performance status of 0 or 1, and measurable disease according to RECIST 1.1 criteria.

Exclusion Criteria: This includes prior treatment for the disease, certain health conditions, and significant recent surgeries or infections.

Primary Objective

Progression-Free Survival (PFS): To assess the progression-free survival at 12 months in participants receiving Toripalimab plus chemotherapy versus those receiving a placebo plus chemotherapy.

Secondary Objectives

Overall Survival (OS): To evaluate overall survival at 12 months.

Objective Response Rate (OR): To determine the objective response rate at 6 months.

Duration of Response (DOR): To assess the duration that patients maintain a response after treatment.

Quality of Life (QoL): To evaluate the impact of the treatment on patients’ quality of life.

Adverse Events (AEs): To monitor and record adverse events experienced by participants during the trial

Study Design: The trial is a Phase II, randomized, double-blinded study comparing Toripalimab plus CAPOX chemotherapy against a placebo plus CAPOX.

Total Participants: The study aims to enroll 190 patients, with 95 in each arm over a span of two years for recruitment, followed by one year of follow-up.

Treatment Arms: Participants will be randomly assigned to one of two arms:

Arm A: Toripalimab plus CAPOX (capecitabine and oxaliplatin).

Arm B: Placebo plus CAPOX

Randomization: Patients are randomized in a 1:1 ratio while stratifying based on PD-L1 status and MSI status, ensuring balanced groups.

Treatment Administration

Group

ARM A:- Toripalimab dose 240 mg on Day 1 of each cycle Q3W given intravenouly

ARM B:- Placebo Day 1 of each cycle Q3W administred intravenously with same method as Toripalimab

Backbone Chemotherapy

CAPOX Oxaliplatin- dose 130 mg/m2 on Day 1 of each cycle Q3W administered intraveously with

capecitabine dose of 1000 mg/m2 twice daily on Days 1 to 14 of each cycle Q3W given orally

Study Followups-

A. Safety Follow-up: Timing: 30 days after the last dose of treatment.

Purpose: To monitor participants for any adverse events (AEs) following the end of their treatment regimen to ensure patient safety and assess any ongoing side effects related to the treatment.

B.Efficacy Follow-up: Timing: Every 9-12 weeks after the last dose of treatment.

Purpose: To evaluate the effectiveness of the treatment by assessing the participants’ response to therapy through regular imaging and clinical evaluations.

C. Survival Follow-up:Timing: Every 12 weeks through telephone contact.

Purpose: To gather information on overall survival and any changes in the participant’s health status, including disease progression or new treatment options post-trial.

2. Imaging and Disease Status Assessment

Participants who discontinue treatment for reasons other than progression of the disease will have post-treatment follow-up imaging conducted to monitor their disease status until any of the conditions for discontinuation are met.

3. Duration of Follow-up

Participants will continue to be followed for overall survival until one of the following conditions occurs:

· The participant passes away.

· The participant withdraws their consent to participate in the study.

· The end of the study period.

4. Additional Follow-up Procedures

After achieving the study objectives, participants may be enrolled in extension studies to continue protocol-defined assessments and treatment, ensuring that data is gathered even after the main study is concluded.

Ethical considerations:- General ethics for the conduct of the study- Study will be conducted in compliance with the ICMR Statement on Human Experimentation, and the Declaration of Helsinki principles. Declaration of Helsinki The trial will be performed in accordance with the Declaration of Helsinki, as decided upon by the 18th World Medical Assembly, Helsinki, Finland, June 1964 (amended by subsequent World Medical Assembly Somerset West, South Africa, October 1996,).