| CTRI Number |
CTRI/2026/04/108053 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
05/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating efficacy of S1 Oxaliplatin in patinets of unresectabe biliary tract malignancies with hyperbilirubinemia |
|
Scientific Title of Study
|
EVALUATING THE EFFICACY AND SAFETY OF S1 – OXALIPLATIN IN PATIENTS OF UNRESECTABLE AND METASTATIC BILIARY TRACT MALIGNANCIES WITH HYPERBILIRUBINEMIA - A PHASE II TRIAL |
| Trial Acronym |
SOX GB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koneti Harshith Sai |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
1202, Sector 15 B, Chandigarh
Medical oncology clinic, 5024A, New opd block, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8074676058 |
| Fax |
|
| Email |
hkoneteatkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor (Dr) Gaurav Prakash |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Prof Gaurav Prakash, Bone marrow trasnsplant ICU, 3rd floor, C block, Nehru hospital, PGIMER, Chandigarh
Medical oncology clinic, 5024A, New opd block, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209678 |
| Fax |
|
| Email |
drgp04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Koneti Harshith Sai |
| Designation |
Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
1202, Sector 15 B, Chandigarh
Medical oncology clinic, 5024A, New opd block, PGIMER, Chandigarh
CHANDIGARH
160015
India |
| Phone |
8074676058 |
| Fax |
|
| Email |
hkoneteatkv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Clinical Hematology and Medical Oncology, PGIMER, Chandigarh, Pin code 160015, Union territory Chandigarh, Country India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Koneti Harshith Sai |
Medical Oncology Clinic, 5024A |
Medical oncology clinic, 5024A, New OPD block,PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8074676058
hkoneteatkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIl |
| Intervention |
S1 Oxaliplatin |
S1 tablet 20 mg/m2,twice daily, 14 days on and 7 days off, Inj Oxaliplatin 85 mg/m2 on day 1; assess disease response at 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
18 -75 years, hyperbilirubinemia post biliary draiange (3.75) in histologically/cytologically confirmed biliary tract malignancy |
|
| ExclusionCriteria |
| Details |
ECOG PS greater than or equal to 3, severe uncontrolled neuropathy, knowns cns disease, prior chemotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease control rate |
12 weeks from the start of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression free survival |
6 months |
| Rate of fall of bilirubin and CA 19.9 |
3 months |
| Note the toxicity profile of S1 and oxaliplatin |
3 months |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
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)
|
16/04/2026 |
| 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="2"
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
|
In patients that continue to have hyperbilirubinemia post biliary drainage, most of these patients are sent on palliation. in this group, administration of S1 - Oxaliplatin may prolong progression free survival and enhance disease control rate |