Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

June 5, 2026 updated by: BO CHEN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postoperative Concurrent Chemoradiotherapy Group
Radiation: Postoperative radiotherapy
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.
Drug: Capecitabine or S-1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year recurrence-free survival (RFS) rate
Time Frame: From completion of radiotherapy until 2 years after radiotherapy
From completion of radiotherapy until 2 years after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
2-year overall survival (OS) rate
Time Frame: From completion of radiotherapy until 2 years after radiotherapy
From completion of radiotherapy until 2 years after radiotherapy
Locoregional control rate
Time Frame: From completion of radiotherapy until 2 years after radiotherapy
From completion of radiotherapy until 2 years after radiotherapy
Incidence of grade ≥3 treatment-related adverse events
Time Frame: From initiation of radiotherapy until 3 months after radiotherapy
From initiation of radiotherapy until 3 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 14, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

May 30, 2029

Study Registration Dates

First Submitted

May 31, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC6244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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