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Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study

RecruitingPhase 2Ages 18 Years - 80 YearsAllCancer Institute and Hospital, Chinese Academy of…
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion 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 1. Narrow resection margin (\<1 cm), including R1 resection 2. Positive circumferential resection margin 3. T stage ≥ T3-4 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: 1. ALT and AST ≤2.5×ULN 2. 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 Exclusion Criteria: * 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
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What it tests

  • Postoperative radiotherapy
  • Capecitabine or S-1
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Where

1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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