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OncoMatch/Clinical Trials/NCT06214572

Radiation Therapy in Unresectable Gall Bladder Cancer

Is NCT06214572 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Systemic therapy (Gemcitabine plus Cisplatin) and Systemic therapy (Gemcitabine plus oxaliplatin) for gall bladder cancer.

Phase 2/3RecruitingTata Memorial CentreNCT06214572Data as of Jun 2026Location: India

Treatment: Systemic therapy (Gemcitabine plus Cisplatin) · Systemic therapy (Gemcitabine plus oxaliplatin) · Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab) · Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Systemic therapy (Gemcitabine plus Cisplatin plus Durvalumab)

Chemotherapy

Systemic therapy (Gemcitabine plus Cisplatin)Systemic therapy (Gemcitabine plus oxaliplatin)Systemic therapy (Gemcitabine plus cisplatin plus nab-paclitaxel)

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: gemcitabine-based chemotherapy — initial

Cannot have received: abdominal therapeutic radiation

Lab requirements

Blood counts

Hb > 80 g/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L

Kidney function

Creatinine ≤ 1.5 ULN, Creatinine clearance >= 50 mL/min

Liver function

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

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06214572 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior abdominal therapeutic radiation disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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