Clinical trial · Interventional
Radiation Therapy in Unresectable Gall Bladder Cancer
Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2/3 Integrated Randomized Clinical Trial
NCT06214572CI-TRIAL-00088462RUGBrecruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gall Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RT | Radiation | — | UNRESOLVED |
| Systemic therapy (Gemcitabine plus Cisplatin) | Drug | — | UNRESOLVED |
| Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab) | Drug | — | UNRESOLVED |
| Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel) | Drug | — | UNRESOLVED |
| Systemic therapy (Gemcitabine plus oxaliplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Systemic therapy
- description
- Participants will receive one of the following Gemcitabine-based systemic therapy alone: 1. Gemcitabine plus cisplatin: Gemcitabine 1000mg/m2 and Cisplatin 25 mg/m2, each administered on Days 1 and 8 every 3 weeks (q3w) 2. Gemcitabine plus oxaliplatin: Gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 IV infusion on days 1 and 8 q2w. 3. 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. 4. 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
- interventionNames
- Drug: Systemic therapy (Gemcitabine plus Cisplatin)
- Drug: Systemic therapy (Gemcitabine plus oxaliplatin)
- Drug: Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)
- Drug: Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)
- type
- ACTIVE_COMPARATOR
- label
- RT (Radiation therapy)
- description
- 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 arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVerma V, Surkar SM, Brooks ED, Simone CB 2nd, Lin C. Chemoradiotherapy Versus Chemotherapy Alone for Unresected Nonmetastatic Gallbladder Cancer: National Practice Patterns and Outcomes. J Natl Compr Canc Netw. 2018 Jan;16(1):59-65. doi: 10.6004/jnccn.2017.7067. PMID 29295882
- BACKGROUNDSinha S, Engineer R, Ostwal V, Ramaswamy A, Chopra S, Shetty N. Radiotherapy for locally advanced unresectable gallbladder cancer - A way forward: Comparative study of chemotherapy versus chemoradiotherapy. J Cancer Res Ther. 2022 Jan-Mar;18(1):147-151. doi: 10.4103/jcrt.JCRT_1568_20. PMID 35381776