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NCT Number: NCT07636824

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

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.

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Key information

Conditions

Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

Postoperative Radiotherapy

Radiation

All patients will receive postoperative concurrent chemoradiotherapy with IMRT or 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.

Capecitabine or S-1

Drug

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.

Primary outcomes

  1. 2-year recurrence-free survival (RFS) rate

    Time frame: From completion of radiotherapy until 2 years after radiotherapy

Secondary outcomes

  1. 2-year overall survival (OS) rate

    Time frame: From completion of radiotherapy until 2 years after radiotherapy

  2. Locoregional control rate

    Time frame: From completion of radiotherapy until 2 years after radiotherapy

  3. Incidence of grade ≥3 treatment-related adverse events

    Time frame: From initiation of radiotherapy until 3 months after radiotherapy

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 9, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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