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Tests treatment safety and results for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Official title Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study
ClinicalTrials.gov ID: NCT07636824
What this study is testing
What is Capecitabine or S-1?
Capecitabine or S-1 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for extrahepatic cholangiocarcinoma and gallbladder carcinoma.
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
- This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Aged 18-80 years
- Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder...
- Postoperative pathology with ≥1 high-risk factor for recurrence
- Narrow resection margin (\<1 cm), including R1 resection
- Positive circumferential resection margin
You likely can't join if
- History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)
- Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)
- Prior abdominal radiotherapy
- Post-organ transplantation
- Symptomatic moderate-severe ascites within 4 months postoperatively
- ≥4 months since surgery
See the full eligibility criteria
- Aged 18-80 years
- Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma
- Postoperative pathology with ≥1 high-risk factor for recurrence
- Narrow resection margin (\<1 cm), including R1 resection
- Positive circumferential resection margin
- T stage ≥ T3-4
- Positive regional lymph nodes
- Postoperative liver function: Child-Pugh grade A5-B7
- No recurrence or metastasis before postoperative radiotherapy
- ECOG performance status 0-2
- Expected survival \>3 months
- Routine blood tests: Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L
- Liver function: Total bilirubin \<1.5×upper limit of normal (ULN), plus one of the following:
- ALT and AST ≤2.5×ULN
- ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)
- Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN
- Voluntary participation and signed informed consent
- History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)
- Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)
- Prior abdominal radiotherapy
- Post-organ transplantation
- Symptomatic moderate-severe ascites within 4 months postoperatively
- ≥4 months since surgery
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. 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.