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New treatment option for Gall Bladder Cancer
Official title Radiation Therapy in Unresectable Gall Bladder Cancer
ClinicalTrials.gov ID: NCT06214572
What this study is testing
What is Systemic therapy (Gemcitabine plus Cisplatin)?
Systemic therapy (Gemcitabine plus Cisplatin) is an investigational medicine, being studied as a potential treatment for gall bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven (biopsy/cytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar...
- Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up...
- 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
You likely can't join if
- 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...
- Pregnancy/Lactating women
See the full eligibility 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
- 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...
- Pregnancy/Lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.