| CTRI Number |
CTRI/2025/07/091458 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study evaluating role of highly dose conformal radiotherapy in management of portal vein tumour thrombus in a case of HCC |
|
Scientific Title of Study
|
Outcomes of Stereotactic Body Radiotherapy in the Management of Portal Vein tumour Thrombosis in Hepatocellular Carcinoma: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sankhya Chatterjee |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7980929212 |
| Fax |
|
| Email |
sankhya53k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kapoor |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872648344 |
| Fax |
|
| Email |
drkapoor.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kapoor |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872648344 |
| Fax |
|
| Email |
drkapoor.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiotherapy and Clinical Oncology, Room no 54, Nehru Hospital Extension Block,
Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, PIN
code- 160012 |
|
|
Primary Sponsor
|
| Name |
Department of Radiotherapy and Clinical Oncology, PGIMER, Chandigarh |
| Address |
Department of Radiotherapy and Clinical Oncology, Postgraduate Institute of
Medical Education and Research (PGIMER), Sector 12, Chandigarh |
| 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 Sankhya Chatterjee |
Department of Radiotherapy and Clinical Oncology, PGIMER, Chandigarh |
Department of Radiotherapy and
Clinical Oncology, Postgraduate
Institute of Medical Education
and Research (PGIMER), Room
no 54, Nehru Hospital Extension
Block, Sector 12, Chandigarh,
PIN code- 160012
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
7980929212
sankhya53k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Hepatocellular Carcinoma (HCC) with radiologically or histologically confirmed portal vein tumor thrombosis (PVTT).
2. ECOG Performance Status of 0–2
3. BCLC stage C
4. Child-Pugh Class A or B liver function status
5. Adequate remaining liver volume, defined as at least 700 cc of uninvolved liver tissue.
|
|
| ExclusionCriteria |
| Details |
1. Presence of metastatic disease outside the liver.
2. Previous radiotherapy to the liver.
3. Child-Pugh Class C liver function status with Child pugh score of 10 to 15.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months.
2. We will also measure the biochemical level of AFP and PIVKAA II before SBRT and after SBRT at 2 months ,4 months and 6 months.
|
1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months.
2. We will also measure the biochemical level of AFP and PIVKAA II before SBRT and after SBRT at 2 months ,4 months and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess acute toxicity profile of SBRT in patients with PVTT, using RTOG scoring criteria. |
at third fraction
1month
2month |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2027 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Management Of Hepatocellular carcinoma with portal vein tumour thrombosis is a challenge in the current era with multiple modalities of treatment available from Radiofrequency ablation , Immunotherapy and Radiotherapy. In this study we will be recruiting patients of HCC with portal vein tumour thrombosis and using Stereotactic Body Radiotherapy technique will be delivering high dose of radiation to the tumour thrombus and then will be serially followed up with imaging to assess response . |