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Tests treatment safety and results for HCC - Hepatocellular Carcinoma
Official 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
ClinicalTrials.gov ID: NCT07521852
What this study is testing
What is CVM-1118 + Sintilimab + TACE?
CVM-1118 + Sintilimab + TACE is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hcc - hepatocellular carcinoma.
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, open-label Phase IIa study designed to evaluate the efficacy, safety, and PK of CVM-1118 in combination with Sintilimab (Tyvyt ®) and TACE in participants with incurable/non-metastatic HCC. Approximately 40 participants will be enrolled, all receiving CVM-1118 (200 mg orally [PO], twice daily [BID]) in combination with Sintilimab (200 mg via intravenous [IV] infusion every 3 weeks [Q3W]) and TACE.
- 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 and older
You may be able to join if
- 1) Participant is ≥18 years of age, at the time of providing the documented informed consent. 2) Diagnosis of hepatocellular carcinoma
- Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD)...
- Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥75 × 10⁹/L; Hemoglobin (HGB) ≥9.0 g/dL without transfusion or...
- Liver Function: Total bilirubin (T-Bil) ≤2 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 ×...
- Renal Function: Non-indexed eGFR ≥ 60 mL/min (formula in Appendix 4)
You likely can't join if
- 1) Known hypersensitivity to CVM-1118, Sintilimab components, or severe allergic reactions to monoclonal antibodies.
- 2) Histologically/cytologically confirmed components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma...
- 3) Has HCC lesions occupying ≥50% of the liver volume. 4) Major portal vein tumor thrombosis involving the main trunk and its first-order branches...
- 5) Is currently a candidate for liver transplantation. 6) Receipt of anti- programmed cell death protein 1 (PD-1), anti- programmed death - ligand 1...
- 7) Receipt of locoregional therapy to existing liver lesions (such as TACE, transcatheter arterial embolization [TAE], transarterial...
- 8) Receipt of prior systemic anticancer therapies for HCC. 9) History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric...
See the full eligibility criteria
Who can join
- 1) Participant is ≥18 years of age, at the time of providing the documented informed consent. 2) Diagnosis of hepatocellular carcinoma
- Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic...
- Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥75 × 10⁹/L; Hemoglobin (HGB) ≥9.0 g/dL without transfusion or erythropoietin (EPO) dependency
- Liver Function: Total bilirubin (T-Bil) ≤2 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; Serum albumin ≥30 g/L
- Renal Function: Non-indexed eGFR ≥ 60 mL/min (formula in Appendix 4)
- Coagulation: International normalized ratio (INR) ≤2 × ULN; prothrombin time (PT) ≤1.5 × ULN 12) Life expectancy of ≥12 weeks. 13) Male and female participants of childbearing potential must agree to use effective...
What rules you out
- 1) Known hypersensitivity to CVM-1118, Sintilimab components, or severe allergic reactions to monoclonal antibodies.
- 2) Histologically/cytologically confirmed components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
- 3) Has HCC lesions occupying ≥50% of the liver volume. 4) Major portal vein tumor thrombosis involving the main trunk and its first-order branches (i.e., Vp3 and Vp4), as demonstrated by imaging performed during the...
- 5) Is currently a candidate for liver transplantation. 6) Receipt of anti- programmed cell death protein 1 (PD-1), anti- programmed death - ligand 1 (PD-L1), or anti - programmed death - ligand 2 (PD-L2) agent or an...
- 7) Receipt of locoregional therapy to existing liver lesions (such as TACE, transcatheter arterial embolization [TAE], transarterial radioembolization (TARE), hepatic arterial infusion, or radiation,) for treatment of...
- 8) Receipt of prior systemic anticancer therapies for HCC. 9) History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6...
- 10) Has bleeding or thrombotic disorders or is using anticoagulants requiring therapeutic INR monitoring, e.g., warfarin or similar agents. Treatment with antiplatelet agents and low molecular weight heparin is...
- 11) Has clinically apparent ascites on physical examination that is not controlled with medication.
- Note: Ascites detectable on imaging studies only are allowed 12) Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Participants on rifaximin or lactulose during screening...
- 13) Has medical contraindications that preclude all forms of contrast enhanced imaging (CT or MRI).
- 14) Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of CVM-1118.
- 15) Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
- 16) Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of investigational product.
- 17) Has significant cardiovascular impairment within 12 months of the first dose of investigational product such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II (Appendix...
- 18) Has had major surgery to the liver within 4 weeks prior to the first dose of investigational product.
- Note: If participant underwent major surgery, they must have adequately recovered from the toxicity and/or complications from the intervention prior to starting investigational product.
- 19) Has had a minor surgery within 7 days prior to the first dose of investigational product.
- 20) Has serious nonhealing wound, ulcer, or bone fracture. 21) Has received a live vaccine within 30 days prior to the first dose of investigational product.
- 22) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of investigational product.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or 5 half-lives (whichever is longer) after the last dose of the previous...
- 23) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the...
- 24) Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g...
- 25) Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are...
- 26) Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- 27) Patients with co-existing active HBV and HCV infections. 28) Has an active infection including tuberculosis or human immunodeficiency virus (positive HIV antibodies).
- 29) Participants with proteinuria \>1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 g/24 hours will be ineligible.
- 30) Has had an allogenic tissue/solid organ transplant. 31) Other conditions that, in the investigator's judgment, would increase study risk, interfere with results, or render the participant ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Shanghai, Shanghai Municipality, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.