Clinical trial for Intrahepatic Cholangiocarcinoma (Icc)
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
ClinicalTrials.gov ID: NCT07847710
What this study is testing
What is Retlirafusp alfa?
Retlirafusp alfa is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for intrahepatic cholangiocarcinoma (icc).
Also referred to as shr-1701.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components.
- Prior systemic therapy or other tumor-related treatment, except biliary drainage.
- Diagnosis of any other malignancy within 5 years before the first study treatment, except cured localized tumors such as cervical carcinoma in situ...
- Known uncontrolled pulmonary fibrosis, interstitial lung disease, or acute lung disease.
- Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment.
- Active hepatitis B or hepatitis C infection.
See the full eligibility 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.
- Life expectancy of at least 12 weeks.
- Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, or other non-cholangiocarcinoma malignant tumor components.
- Prior systemic therapy or other tumor-related treatment, except biliary drainage.
- 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.
- Participation in another clinical trial of an investigational drug or device within 4 weeks before the first study treatment.
- Active hepatitis B or hepatitis C infection.
- Active autoimmune disease requiring systemic treatment within 2 years before the first
The study team makes the final eligibility decision.
Where it is enrolling
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nanjing, Jiangsu, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.