OncoMatch/Clinical Trials/NCT07847710
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Official title: Perioperative Retlirafusp Alfa（Anti-PD-L1/TGF-β Bifunctional Fusion Protein） Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial: H-FROG Feasibility Study
Is NCT07847710 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for intrahepatic cholangiocarcinoma (icc).
Treatment: Rilvegostomig Alpha · Famitinib malate · Gemcitabine & oxaliplatin · Capecitabine · S-1 — This is a multicenter, single-arm, exploratory clinical study for adults with locally advanced intrahepatic cholangiocarcinoma (ICC) that may be technically resectable but is difficult to remove directly by surgery. The study will evaluate whether perioperative treatment with Retlirafusp alfa, famitinib malate, and hepatic arterial infusion chemotherapy using gemcitabine and oxaliplatin (HAIC-GEMOX) can help control the tumor before surgery and support further treatment after surgery. Participants who meet the study requirements will receive neoadjuvant treatment before surgery. After surgery, participants will receive adjuvant treatment with Retlirafusp alfa combined with capecitabine or S-1. The study treatment and follow-up will continue until disease progression, unacceptable side effects, death, withdrawal of consent, or other protocol-defined stopping criteria. The main purpose of the study is to evaluate event-free survival. The study will also monitor tumor response, surgery-related outcomes, survival, and safety. Participants will have regular safety visits, blood tests, imaging examinations, and follow-up visits during and after treatment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic therapy or other tumor-related treatment
Exception: biliary drainage
No prior systemic therapy or tumor-related surgery, except biliary drainage
Lab requirements
Blood counts
Adequate organ and bone marrow function, as defined by the protocol
Kidney function
Adequate organ and bone marrow function, as defined by the protocol
Liver function
Adequate organ and bone marrow function, as defined by the protocol
Adequate organ and bone marrow function, as defined by the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07847710 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages