Postoperative chemoradiotherapy for extrahepatic cholangiocarcinoma and gallbladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm Phase II trial enrolling patients who have undergone curative resection for extrahepatic cholangiocarcinoma or gallbladder carcinoma and have high-risk features for recurrence. Participants receive postoperative concurrent chemoradiotherapy using IMRT or VMAT, with targeted doses to the tumor bed and regional lymph nodes, along with oral capecitabine. The trial aims to determine safety and preliminary efficacy of this postoperative approach in a defined high-risk population. Eligibility includes adequate organ function, good performance status, and absence of residual disease or metastasis at radiotherapy start.

Why it matters

Who can join: the full rules

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

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Bo Chen, MD
• Email: chenboo@outlook.com
• Phone: 00861324000876

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.