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
| NCT ID | NCT07847710 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Intrahepatic Cholangiocarcinoma (Icc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2026-09-30 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 81 participants in total. It began in 2026-09-30 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Feng Cheng, MD
STUDY DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07847710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Intrahepatic Cholangiocarcinoma (Icc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07847710 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07847710 currently recruiting?
Yes, NCT07847710 is actively recruiting participants. Contact the research team at lvling@njmu.edu.cn for enrollment information.
Where is the NCT07847710 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07847710 clinical trial?
NCT07847710 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Feng Cheng, MD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 81 participants.