Based on unmet clinical needs, relevant research backgrounds, and scientific evidence, it is planned to conduct a prospective, dual-cohort exploratory study. The aim of this study is to explore the efficacy and safety of ricartuzumab combined with pertuzumab and epalrestat-vorolizumab in the first-line treatment of HER2-expressing locally advanced or metastatic biliary tract cancer. It is expected to provide more treatment options for biliary tract cancer patients, optimize treatment strategies, and improve patients' long-term survival rates.
Patients must voluntarily participate in the trial, provide fully informed consent with signed written documentation, and demonstrate good compliance.
Age between 18 and 75 years (inclusive), calculated as of the day of signing the informed consent form; both male and female patients are eligible.
Patients must have histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer, including: Cholangiocarcinoma (intrahepatic or extrahepatic) and Gallbladder carcinoma
HER2 Expression Criteria: HER2 Overexpression: IHC 3+ OR IHC 2+ with FISH-positive (gene amplification); HER2 Moderate/Low Expression: Moderate: IHC 2+ with FISH-negative (no gene amplification) Low: IHC 1+ (any level of HER2 staining)
Histologically or cytologically confirmed ampullary carcinoma, small cell carcinoma, neuroendocrine tumors, sarcoma, mucinous cystic neoplasms, or other rare biliary tract malignancies.
Active other malignancies within 5 years or concurrently.
History of leptomeningeal disease, brain metastases, or current brain metastases.
Participation in other investigational drug trials within the past 3 months, or concurrent enrollment in another interventional clinical trial (observational/non-interventional studies or follow-up phases allowed).
Parallel
Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Overexpression BTC
DrugSubjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.
Trastuzumab-rezetecan + Pertuzumab + Iparomlimab and Tuvonralimab for HER2 Moderate/Low BTC
DrugSubjects received treatment with Iparomlimab and Tuvonralimab (5.0 mg/kg, iv, d1, q3w) and Trastuzumab-rezetecan (4.8 mg/kg, iv, d1, q3w) in combination with Pertuzumab (initial dose 840 mg, iv, followed by 420 mg, iv, d1, q3w). Study treatment continued until the occurrence of a protocol-specified treatment discontinuation event. Following the end of treatment, subjects will continue to undergo safety follow-up and survival follow-up. For subjects who discontinued treatment for reasons other than disease progression, periodic tumor imaging assessment follow-up will also continue after treatment cessation.
Objective Response Rate (ORR) by RECIST1.1
Objective Response Rate (ORR) assessed by investigators based on the Response EvaluationCriteria in Solid Tumors version 1.1 (RECIST v1.1).
Objective Response Rate (ORR) by mRECIST
Objective Response Rate (ORR) assessed by investigators based on the modified Response Evaluation Criteria in Solid Tumors mRECIST.
DCR
The percentage of subjects who achieved complete response, partial response, or stable disease (SD) lasting for 6 weeks or longer, as determined by the investigator in accordance with RECIST v1.1 or mRECIST.
OS
The time from the date of the first drug administration to the death of the subject due to various reasons.
TTP
The time from the date of the first treatment to the occurrence of radiological disease progression, as determined by the investigator in accordance with RECIST v1.1 or mRECIST.
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