Actively Recruiting
A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic (PK) of CVM-1118 in Combination With Sintilimab and Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
Led by TaiRx, Inc. · Updated on 2026-04-22
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of CVM-1118, Sintilimab (Tyvyt®), and Transarterial Chemoembolization (TACE) in participants with incurable and non-metastatic hepatocellular carcinoma (HCC). This Phase IIa, single-arm, open-label study aims to assess how well this regimen works, its safety, and how the body processes these drugs. Approximately 40 participants will be enrolled, focusing on those with liver cancer not suitable for surgery or transplantation and without cancer spread outside the liver. Participants will receive CVM-1118 orally at 200 mg twice daily and Sintilimab intravenously at 200 mg every three weeks. The first TACE procedure will take place 2 to 4 weeks after starting systemic therapy, with up to 4 TACE treatments per participant and a maximum of 2 treatments per lesion. CVM-1118 is temporarily paused 2 days before and resumed 7 days after each TACE. Treatment continues until unacceptable side effects, disease progression, death, consent withdrawal, for up to 2 years, or study end. The choice between conventional TACE and drug-eluting beads TACE is made by the investigator but remains consistent per participant. During the study, participants undergo screening evaluations before starting treatment. Tumor response is assessed every 9 weeks using standard imaging criteria. Safety assessments are done 28 days after treatment ends or before new cancer therapy begins. Afterward, survival follow-up contacts occur every 12 weeks to track disease status and treatments until death, loss to follow-up, withdrawal, or study closure. Blood samples will be collected to study drug levels, and safety is monitored throughout. The entire process may last up to 4 years to observe long-term outcomes.
CONDITIONS
Brief Title
A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Participants With Incurable/Non-metastatic HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older at the time of providing informed consent.
- Diagnosis of hepatocellular carcinoma confirmed by pathology, cytology, or imaging per AASLD criteria.
- No evidence of cancer spread outside the liver.
- Disease not suitable for curative surgery, transplantation, or ablation.
- Disease amenable to up to 4 TACE treatments, with a maximum of 2 treatments per lesion.
- Child-Pugh liver function class A.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status of 0 to 1.
- Stable or treated hepatitis B or hepatitis C infection with agreement to receive treatment during the trial.
- Adequate organ and bone marrow function based on specified lab criteria.
- Life expectancy of at least 12 weeks.
- Agreement to use effective contraception for participants of childbearing potential.
- Signed informed consent and ability to comply with study procedures.
You will not qualify if you...
- Known allergy to CVM-1118, Sintilimab, or monoclonal antibodies.
- Diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid HCC, cholangiocarcinoma, or similar.
- HCC lesions occupying 50% or more of liver volume.
- Major portal vein tumor thrombosis involving main branches.
- Candidate for liver transplantation.
- Prior treatment with PD-1, PD-L1, PD-L2 agents or other immune checkpoint therapies.
- Prior locoregional therapy for HCC except curative-intent TACE or TAE.
- Previous systemic anticancer therapy for HCC.
- Recent serious gastrointestinal bleeding or non-healed ulcers.
- Bleeding disorders requiring therapeutic anticoagulation.
- Uncontrolled ascites or recent hepatic encephalopathy.
- Contraindications to contrast-enhanced imaging.
- Gastrointestinal conditions affecting drug absorption.
- Grade 3 or higher fistula.
- Significant tumor bleeding or hemoptysis recently.
- Recent major cardiovascular events or impairments.
- Recent major or minor surgery not recovered.
- Serious non-healing wounds or fractures.
- Recent live vaccine use.
- Participation in other investigational studies within 4 weeks.
- Immunodeficiency or recent immunosuppressive therapy.
- Active autoimmune disease requiring treatment in past 2 years.
- Active infections including tuberculosis or HIV.
- Significant proteinuria exceeding specified limits.
- History of organ transplant.
- Any condition increasing study risk or interfering with results as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles with up to 4 TACE treatments
Participants receive combination treatment with CVM-1118 taken orally twice daily, Sintilimab given intravenously every 3 weeks, and up to 4 Transarterial Chemoembolization (TACE) procedures.
Visits every 3 weeks for Sintilimab dosing and TACE sessions up to 4 times
Duration - Up to approximately 4 years
Participants are monitored for safety and efficacy outcomes after completing treatment, including survival and disease progression assessments up to 4 years.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chun-Man Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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