OncoMatch/Clinical Trials/NCT07636824
Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study
Is NCT07636824 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Capecitabine or S-1 for extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Treatment: Capecitabine or S-1 — 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. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg/m² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg/m² on Days 1-14, every 21 days for 6 cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles. The primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events. A total of 92 patients are planned for enrollment in this trial.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: abdominal radiotherapy
Prior abdominal radiotherapy
Lab requirements
Blood counts
Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L
Kidney function
Creatinine and blood urea nitrogen ≤2.5×ULN
Liver function
Child-Pugh grade A5-B7; Total bilirubin <1.5×ULN; ALT and AST ≤2.5×ULN or ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)
Routine blood tests: Neutrophils ≥1.0×10⁹/L, hemoglobin ≥80 g/L, platelets ≥100×10⁹/L; Liver function: Child-Pugh grade A5-B7, Total bilirubin <1.5×ULN, ALT and AST ≤2.5×ULN or 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07636824 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior abdominal radiotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages