NCT07636824RecruitingPhase 2
Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 31 May 2026
- Start date
- 16 Jun 2026
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07636824
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 92
- From 16 Jun 2026 to the primary completion date, 28 Feb 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior abdominal radiotherapy
- Post-organ transplantation
- ≥4 months since surgery
Other illness
- 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)
Other
- Symptomatic moderate-severe ascites within 4 months postoperatively
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.