Retlirafusp alfa, famitinib and liver-directed chemotherapy around surgery for intrahepatic cholangiocarcinoma
Tests retlirafusp alfa, famitinib and chemotherapy around surgery in adults with intrahepatic cholangiocarcinoma.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07847710, who can take part
Where in China
- The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital with Nanjing Medical University
- Trial code
- NCT07847710
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants must meet all of the following criteria:; Voluntarily agree to participate in the study and sign the informed consent form; Age 18 to 75 years at the time of signing informed consent, male or female; Histologically and/or cytologically confirmed intrahepatic cholangiocarcinoma; ECOG performance status of 0 to 1; No prior systemic therapy or tumor-related surgery, except biliary drainage; No extrahepatic metastasis; Considered technically resectable by an experienced hepatobiliary surgeon; At least one measurable lesion according to RECIST 1.1; Adequate organ and bone marrow function, as defined by the protocol; Women of childbearing potential must have a negative serum pregnancy test within 7 days before treatment and agree to use effective contraception during the study and for 1 year after the last study treatment. Male participants with partners of childbearing potential must also agree to use effective contraception during the study and for 1 year after the last study treatment; Life expectancy of at least 12 weeks.
Exclusion: Prior systemic therapy or other tumor-related treatment, except biliary drainage; Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment; Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components; Diagnosis of any other malignancy within 5 years before the first study treatment, except cured localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, or low-grade prostate cancer; Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease; Active hepatitis B or hepatitis C infection; Active autoimmune disease requiring systemic treatment within 2 years before the first; Participants meeting any of the following criteria will be excluded:.