NCT07847710RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07847710
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 81
- From 30 Sept 2026 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Participants meeting any of the following criteria will be excluded:
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.