💬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 study. Eligible patients with lymph node-positive biliary tract cancer will undergo primary tumor resection with selective lymph node dissection. During surgery, the regional and retroperitoneal lymph nodes will be explored, and lymph nodes that are technically amenable to surgical resection will be dissected. Metastatic lymph nodes that cannot be safely or completely resected because of local invasion or because of their location beyond the feasible surgical dissection field will not be surgically resected and will subsequently be treated with postoperative radiotherapy. Following surgery, patients will receive postoperative radiotherapy to the primary tumor bed and involved/regional lymph node areas. For patients who undergo R0 or R1 resection, concurrent chemoradiotherapy with capecitabine or S-1 will be admi
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📋 Eligibility rules (as published)
Inclusion Criteria:
1. Patients with suspected biliary tract carcinoma who are eligible for surgical exploration, with postoperative pathological confirmation of biliary tract adenocarcinoma;
2. Age 18-80 years;
3. Preoperative assessment indicating that the primary tumor is potentially amenable to R0/R1 resection;
4. Preoperative evidence of lymph node metastases with at least one of the following features indicating that complete surgical resection or lymph node dissection may not be feasible:
* Local invasion of regional lymph nodes, such that complete surgical resection may not be feasible;
* Retroperitoneal lymph node metastases extending beyond the feasible surgical dissection field;
5. Whole-body PET/CT demonstrating metastatic lymph node involvement confined to a contiguous extended lymphatic field that can be encompassed within a single radiotherapy plan, with the involved lymph nodes extending from the lower paraesophageal lymph node region superiorly to the lymph nodes at the level of the abdominal aortic bifurcation inferiorly;
6. No distant organ metastases, non-regional lymph node metastases, or intrahepatic metastatic lesions are allowed. Isolated right internal mammary lymph node or left supraclavicular lymph node involvement is permitted; however, these lesions will not be included in the initial radiotherapy field and may receive subsequent definitive local radiotherapy based on multidisciplinary evaluation and treatment response;
7. Prior systemic therapy, including chemotherapy, targeted therapy, or immunotherapy, is permitted. Prior local treatment, including interventional therapy or radiofrequency ablation, is not permitted;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a life expectancy of \>3 months;
9. Child-Pugh class A5 or A6;
10. Liver function meeting the following criteria:
* ALT ≤2.5 × the upper limit of normal (ULN), with AST ≤6 × ULN when ALT ≤1.5 × ULN and AST ≤2.5 × ULN when ALT \>1.5 × ULN but ≤2.5 × ULN, after excluding AST elevation due to myocardial infarction;
* Total bilirubin (TBIL) \<60 μmol/L.
11. No clinically significant abnormalities on electrocardiography, no significant cardiac insufficiency, and no contraindication to treatment with PD-1/PD-L1 inhibitors;
12. Adequate renal function, defined as serum creatinine (CRE) and blood urea nitrogen (BUN) ≤2.5 × ULN;
13. Adequate hematologic function, defined as hemoglobin (Hb) ≥80 g/L, absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, and platelet count (PLT) ≥80 × 10⁹/L;
14. Patients voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion Criteria:
1. Current participation in another interventional clinical trial involving an investigational drug or treatment;
2. Previous abdominal radiotherapy or liver transplantation;
3. Previous local treatment for the current malignancy, including interventional therapy or radiofrequency ablation;
4. Known or suspected drug dependence, substance abuse, or alcohol abuse;
5. Pregnancy or breastfeeding;
6. Severe psychiatric or neurological disorders that may interfere with the ability to provide informed consent or with the reporting or assessment of adverse events;
7. Concurrent second primary malignancy or a history of another malignancy diagnosed within 3 years before enrollment, except for superficial skin cancers, localized low-grade malignancies, or carcinoma in situ that have been adequately treated and are not considered potentially life-threatening due to disease progression;
8. Severe unhealed wounds, ulcers, or fractures;
9. Biliary fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before enrollment;
10. Unstable angina, myocardial infarction, coronary artery bypass grafting, congestive heart failure, or cerebrovascular events, including transient ischemic attack or pulmonary embolism, within 3 months before enrollment;
11. Persistent arrhythmia of CTCAE grade ≥2, atrial fibrillation of any grade, or prolonged QTc interval (QTc \>450 ms in males or \>470 ms in females);
12. Known HIV infection.
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