Radiation Therapy in Unresectable Gall Bladder Cancer

NCT06214572 · tracked via the Priya Life Science India tracker

Sponsor

Tata Memorial Centre

Phase

Phase 2/3

Started

2024-03-07

Last updated

2025-04-11

Condition(s) studied

Gall Bladder Cancer

Investigational drug(s) / intervention(s)

Systemic therapy (Gemcitabine plus Cisplatin) →RTSystemic therapy (Gemcitabine plus oxaliplatin) →Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)All Cisplatin trials (514) →All Durvalumab trials (220) →Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)All Cisplatin trials (514) →All Nab-paclitaxel trials (233) →

Systemic therapy (Gemcitabine plus Cisplatin): Participants will receive one of the following Gemcitabine-based systemic therapy alone: Gemcitabine 1000mg/m2 and Cisplatin 25 mg/m2, each administered on Days 1 and 8 every 3 weeks (q3w) Duration: 3 months (in addition to 3 months previously received)

RT: Participants will receive radiation therapy in addition to systemic therapy Hypofractionated external image guided radiation to a dose of 40-55Gy in 10 sessions (up to 60Gy in 15 sessions) over 2-3 weeks. This is followed by systemic therapy as in the Systemic therapy alone arm.

Systemic therapy (Gemcitabine plus oxaliplatin): Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. Duration: 3 months

Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab): Durvalumab 1500 mg via intravenous (IV) infusion q4w, starting on Cycle 1 in combination with cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 each administered on Days 1 and 8, q3w. Duration 3 months Durvalumab (12 months)

Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel): Gemcitabine 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel 100 mg/m2, on days 1 and 8, q3w Duration: 3 months

Study summary

The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and/or immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are:

* Whether adding radiation therapy to systemic therapy improves overall survival?
* What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically proven (biopsy/cytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar cholangiocarcinoma will also be included. * Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up recommended in the joint clinic. * Locally advanced disease with one or more of the following * Extensive liver infiltration not amenable for surgery but feasible for safe radiation delivery (Liver minus gross tumor volume at least 700cc) * Vascular involvement: encasement (\>180-degree angle) of one of the vessels: Hepatic artery, main portal vein, right or left portal vein * Obstructive jaundice with hilar involvement (type 2 non communicating block and higher blocks as per Bismuth-Corlette classification) * Stable disease or partial response (RECIST 1.1) after initial 3 months of Gemcitabine based chemotherapy * More than 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 fit for chemotherapy * Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy * Hematological- Hb\> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L. * Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g/L * Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \>= 50 mL/min Exclusion Criteria: * Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded. * Prior abdominal therapeutic radiation * Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix * Pregnancy/Lactating women

Primary outcome measure(s)

Median overall survival — 2 years
Time interval between the date of diagnosis and death due to any case.

Trial sites (1)

Facility	City	Region	Status
Tata Memorial Centre	Mumbai	Maharashtra	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06214572 on ClinicalTrials.gov ↗ ← All trials in India