This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.
The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.
When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.
Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)
Having undergone radical surgical treatment (R0 or R1 resection)
Pancreatic cancer or ampullary cancer
Not yet fully recovered from the surgery or with unremoved bile duct obstruction
Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical cancer, treated superficial bladder cancer, and prostate adenocarcinoma that underwent surgical treatment and whose PSA tumor marker was within the normal range.
Parallel
Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib
Combination productRegimen of durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib
Capecitabine
DrugCapecitabine monotherapy regimen
1-year recurrence-free survival
1-year recurrence-free survival refers to the proportion of patients who remain alive and free of disease recurrence at 12 months after the initiation of treatment (e.g., surgery or start of systemic therapy).
Overall Survival
Overall Survival (OS) was defined as the time from randomization (or treatment initiation) to death from any cause.
Adverse reaction event
Blood test，Outpatient follow-up and telephone follow-up
Serious adverse events
SAEs were prospectively collected through electronic medical records.
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