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HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer

RecruitingNAAges 18 Years - 80 YearsAllPeking University
NCT07466238 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Biliary tract cancer (BTC), including cholangiocarcinoma and gallbladder cancer (GBC), is a group of malignancies with highly heterogeneous, highly aggressiveness, and poor prognosis. Surgery is recognized as the only curative treatment for BTC, however, only about 20% BTC patients are eligible for curative resection since most patients with BTC are diagnosed at an advanced stage. The median overall survival (OS) in patients with unresectable BTC is typically less than 6 months. For patients with unresectable BTC, gemcitabine plus cisplatin (GemCis) had been recommended as the standard first-line treatment for many years. However, the objective response rate (ORR) of this regimen is only 26.1%, and the survival benefit remains limited, with a median OS of less than one year. In recent years, two phase III trials (TOPAZ-1 and KEYNOTE-966) have demonstrated that combining immune checkpoin

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 18-80 years, both genders. * Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination. * Without distant metastasis or limited distant metastasis * Treatment-naive. * ECOG PS score \< 2. * Child-Pugh score: Class A or B (≤7). * Normal major organ function, meeting the following standards:(1) Blood routine examination:A. Hb≥90 g/L;B. ANC≥1.5×10\^9/L;C. PLT≥75×10\^9/L;(2) Biochemical examination:A. ALB ≥30g/L;B. ALT and AST\<5×ULN;C. TBiL ≤5×ULN;D. Creatinine ≤1.5×ULN;(3) Coagulation function:A. International normalized ratio (INR) ≤1.5×ULN;B. Activated partial thromboplastin time (APTT) ≤1.5×ULN. Exclusion Criteria: * Coexistent or synchronous malignancies. * Distal cholangiocarcinoma. * Allergic to contrast agents or oxaliplatin. * Pregnant or lactating women. * Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions. * History of organ transplantation. * With infections requiring anti-infection treatment. * Severe and irreparable coagulation dysfunction.
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What it tests

  • HAIC(GOLF)
  • Bevacizumab
  • PD-1/PD-L1 inhibitor
  • HAIC (FOLFOX)
  • Gemcitabin
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Where

2 sites
Peking University Cancer Hospital
Beijing, China
Peking University Cancer Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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