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
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
- Intrahepatic Cholangiocarcinoma (Icc)
- Neoadjuvant Therapy
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrolment target
- 81
- Started
- 1 August 2026
- Main results due
- 1 March 2028
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: Participants must meet all of the following criteria: 1. Voluntarily agree to participate in the study and sign the informed consent form. 2. Age 18 to 75 years at the time of signing informed consent, male or female. 3. Histologically and/or cytologically confirmed intrahepatic cholangiocarcinoma. 4. ECOG performance status of 0 to 1. 5. No prior systemic therapy or tumor-related surgery, except biliary drainage. 6. No extrahepatic metastasis. 7. Considered technically resectable by an experienced hepatobiliary surgeon. 8. At least one measurable lesion according to RECIST 1.1. 9. Adequate organ and bone marrow function, as defined by the protocol. 10. 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. 11. Life expectancy of at least 12 weeks. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components. 2. Prior systemic therapy or other tumor-related treatment, except biliary drainage. 3. 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. 4. Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease. 5. Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment. 6. Active hepatitis B or hepatitis C infection. 7. Active autoimmune disease requiring systemic treatment within 2 years before the first
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07847710. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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