HCC - Hepatocellular CarcinomaPhase 2NCT07521852
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
A Phase 2 study testing CVM-1118 + Sintilimab + TACE in people with HCC - Hepatocellular Carcinoma, run by TaiRx, Inc. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- CVM-1118 + Sintilimab + TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 contrast computed tomography [CT] or magnetic resonance imaging [MRI] showing a ≥ 1 cm liver lesion).
- 3) No evidence of extrahepatic disease on any available imaging. 4) Disease not amenable to curative surgery or transplantation or curative ablation.
- 5) Disease must be amenable to TACE and anticipated to require no more than 4 TACE treatments for local disease sites, with a maximum of 2 TACE treatments per individual lesion .
- 6) Child-Pugh liver function class A (see Appendix 2). 7) At least one measurable (per RECIST 1.1) lesion (see Appendix 1). 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (see Appendix 3).
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- 9) Patients with hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBcAb) positive, and HBV DNA detected positive (≥10 IU/ml or above the local laboratory's standard detection limit), who have stable disease or show antiviral response (e.g., reduction in HBV DNA levels) after treatment, and agree to receive treatment during the trial, shall be allowed to enroll.
- 10) Patients with hepatitis C virus (HCV) infection who agree to receive treatment during the trial are eligible for enrollment.
- 11) Participants must have adequate organ and bone marrow function, meeting the following laboratory criteria:
- 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 contraception from the signing of the informed consent form (ICF) until 6 months after the last dose of the investigational product. Female participants of childbearing potential are defined as premenopausal women. A negative pregnancy test result must be confirmed for all female of childbearing potential within ≤7 days prior to the first dose of the investigational product.
- 14) Signed written informed consent form and ability to comply with protocol-specified visits and related procedures.
Who cannot join
- 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 screening period.
- 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 agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T - lymphocyte - associated protein 4 [CTLA-4]).
- 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 HCC. Use of TACE or TAE as part of a curative therapy (e.g., in conjunction with ablation or surgery) can be acceptable if it is used in the lesions where curative therapy was attempted. However, TACE or TAE cannot have been used as sole modalities in prior curative therapy.
- 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 months prior to enrollment.
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- 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 permitted.
- 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 to control their hepatic encephalopathy are excluded.
- 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 5), unstable angina, myocardial infarction or cerebrovascular accident stroke, or cardiac arrhythmia associated with hemodynamic instability.
- 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 investigational agent.
- 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 first dose of investigational product.
- 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., thyroxine, insulin, or physiologic corticosteroid replacement therapy [e.g., ≤10 mg prednisone] for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.
- 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 not excluded.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
MengChao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
Yong Yi Zeng, +86 0591-88110232, lamp197311@126.com
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jia Fan, 021-64041990, fan.jia@zs-hospital.sh.cn
About this study
Official title: 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
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. All participants will initiate treatment with CVM-1118 and Sintilimab on Cycle 1 Day 1 (C1D1), with each cycle lasting 21 days, continuing until the occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. The protocol permits conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) based on investigator's discretion, with the requirement that each participant maintains the same TACE modality throughout the treatment period. The first TACE procedure will be initiated between weeks 2-4 (C1D15 - C2D8) following systemic therapy initiation, with a maximum of 2 TACE treatments per lesion, an interval of ≥1 month between TACE sessions, and no more than 4 TACE treatments in total per participant.
Read more
The study comprises four periods: screening, treatment, safety follow-up, and survival follow-up. During the screening period, participants will undergo required examinations and evaluations. Eligible participants will enter the treatment period to receive the combination regimen. Tumor response will be assessed per RECIST v1.1 and mRECIST (see Appendix 1), with evaluations conducted every 9 weeks (±1 week) following initial dosing. During the safety follow-up period, all participants will undergo final safety assessments 28 days (+7 days) after investigational product cessation or prior to initiating new antitumor therapy. Subsequently, participants will enter the survival follow-up period with 12-week interval contacts to document disease status, anti-tumor therapies received, survival status, and other relevant clinical information until death, loss to follow-up, consent withdrawal, or study closure (whichever occurs first).
Throughout the study, participants will undergo scheduled safety evaluations and PK blood sampling at designated timepoints. Subsequent PK sampling schedules may be adjusted or eliminated based on accumulated pharmacokinetic data from preceding participants.
- CVM 1118 will be administered at 200 mg, PO, BID. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34), or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. CVM-1118 should be swallowed whole with a glass of water in a fasted state, with no food intake for at least 2 hours before and 1 hour after CVM 1118 administration. CVM 1118 should be administered at approximately the same time each day. Investigators are permitted to adjust the dosing for participants as required by referring to the "Dose Adjustment".
- Sintilimab will be administered at 200 mg, IV, Q3W. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). Investigators are permitted to adjust the drug administration regimen for participants as required by referring to the "Dose Adjustment".
- TACE modality for each participant, including the choice between cTACE and DEB-TACE, will be determined by investigators at their discretion; however, each participant must remain consistent with the selected TACE modality (cTACE or DEB-TACE) throughout the treatment period. The first TACE procedure will be initiated 2-4 weeks after the start of systemic therapy (C1D15 to C2D8), with a maximum of 2 treatments per lesion (minimum 1-month interval between TACE sessions) and up to 4 treatments per participant in total.
Read the detailed description
This study is conducted in China and is not under a U.S. IND. However, the investigational product is a U.S. FDA-regulated drug with existing INDs [125830, 138523, 138900], and the data from this study are intended to support a future U.S. marketing application.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- CVM-1118 + Sintilimab + TACE
- Keywords
- Oncology, Hepatocellular Carcinoma (HCC), Hepatoma, TACE, Sintilimab, CVM-1118
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVM-1118 + Sintilimab + TACECombination product
CVM-1118 (200 mg, PO, BID) + Sintilimab (200 mg, IV, Q3W) + TACE (4 times in maximum)
| Study group | Role | What they receive |
|---|---|---|
| CVM-1118 + Sintilimab + TACE | Experimental | CVM-1118 (200 mg, PO, BID) + Sintilimab (200 mg, IV, Q3W) + TACE (4 times in maximum) Receives: Combination Product: CVM-1118 + Sintilimab + TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 2 years
Secondary outcomes (13)
Objective Response Rate (ORR)_mRECIST
Assessment by modified RECIST criteria
Measured: Up to approximately 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1 and mRECIST
Measured: Up to approximately 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Measured: Up to approximately 2 years
Progression free survival (PFS)
Progression free survival (PFS) is defined as time from the first dose of study drug to the time of progression or death
Measured: Up to approximately 2 years
Time to progression (TTP)
Time to progression (TTP) is defined as the time from the first dose of study drug to the time of progression
Measured: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) is defined as time from first dose of study drug to death
Measured: Up to approximately 4 years
Rate of Adverse event (AE) and Serious Adverse Event (SAE)
Rate of Adverse event (AE) and Serious Adverse Event (SAE) are assessed using Common Terminology Criteria for Adverse Events v.6 (CTCAE) criteria
Measured: Starting from the first dose of combination treatment until 28 days following the last dose of treatment by CTCAE v6.
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 will be measured to see maximum exposure after CVM-1118 dosing
Measured: During Cycle 1 (each cycle is 21 days)
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Measured: During Cycle 1 (each cycle is 21 days)
Peak time(Tmax) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Peak time(Tmax) is to evaluate the Pharmacokinetics(PK) of CVM-1118 and its metabolite CVM-1125
Measured: During Cycle 1 (each cycle is 21 days)
Half time(t1/2) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Half time(t1/2) is to evaluate the Pharmacokinetics(PK) of CVM-1118 and its metabolite CVM-1125
Measured: During Cycle 1 (each cycle is 21 days)
Clearance rate(CL) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Clearance rate(CL) is to evaluate the Pharmacokinetics(PK) of CVM-1118 and its metabolite CVM-1125
Measured: During Cycle 1 (each cycle is 21 days)
Apparent volume of distribution(Vd) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Apparent volume of distribution(Vd) is to evaluate the Pharmacokinetics(PK) of CVM-1118 and its metabolite CVM-1125
Measured: During Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CVM-1118 in Combination with Sintilimab and TACE
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521852
- Sponsor's protocol ID
- CVM-010
- Other IDs
- IND125830, IND138523
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07521852
- Acronym / sponsor ID
- CVM-010
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Oncology, Hepatocellular Carcinoma (HCC), Hepatoma, TACE, Sintilimab, CVM-1118
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TaiRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. All participants will initiate treatment with CVM-1118 and Sintilimab on Cycle 1 Day 1 (C1D1), with each cycle lasting 21 days, continuing until the occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. The protocol permits conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) based on investigator's discretion, with the requirement that each participant maintains the same TACE modality throughout the treatment period. The first TACE procedure will be initiated between weeks 2-4 (C1D15 - C2D8) following systemic therapy initiation, with a maximum of 2 TACE treatments per lesion, an interval of ≥1 month between TACE sessions, and no more than 4 TACE treatments in total per participant.
The study comprises four periods: screening, treatment, safety follow-up, and survival follow-up. During the screening period, participants will undergo required examinations and evaluations. Eligible participants will enter the treatment period to receive the combination regimen. Tumor response will be assessed per RECIST v1.1 and mRECIST (see Appendix 1), with evaluations conducted every 9 weeks (±1 week) following initial dosing. During the safety follow-up period, all participants will undergo final safety assessments 28 days (+7 days) after investigational product cessation or prior to initiating new antitumor therapy. Subsequently, participants will enter the survival follow-up period with 12-week interval contacts to document disease status, anti-tumor therapies received, survival status, and other relevant clinical information until death, loss to follow-up, consent withdrawal, or study closure (whichever occurs first).
Throughout the study, participants will undergo scheduled safety evaluations and PK blood sampling at designated timepoints. Subsequent PK sampling schedules may be adjusted or eliminated based on accumulated pharmacokinetic data from preceding participants.
- CVM 1118 will be administered at 200 mg, PO, BID. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34), or study termination (whichever occurs first). CVM-1118 will be temporarily suspended from 2 days prior to each TACE procedure until 7 days post-TACE. CVM-1118 should be swallowed whole with a glass of water in a fasted state, with no food intake for at least 2 hours before and 1 hour after CVM 1118 administration. CVM 1118 should be administered at approximately the same time each day. Investigators are permitted to adjust the dosing for participants as required by referring to the "Dose Adjustment".
- Sintilimab will be administered at 200 mg, IV, Q3W. Treatment continues until unacceptable toxicity, disease progression, death, consent withdrawal, for 2 years (i.e., Cycle 34) or study termination (whichever occurs first). Investigators are permitted to adjust the drug administration regimen for participants as required by referring to the "Dose Adjustment".
- TACE modality for each participant, including the choice between cTACE and DEB-TACE, will be determined by investigators at their discretion; however, each participant must remain consistent with the selected TACE modality (cTACE or DEB-TACE) throughout the treatment period. The first TACE procedure will be initiated 2-4 weeks after the start of systemic therapy (C1D15 to C2D8), with a maximum of 2 treatments per lesion (minimum 1-month interval between TACE sessions) and up to 4 treatments per participant in total.
Detailed description
This study is conducted in China and is not under a U.S. IND. However, the investigational product is a U.S. FDA-regulated drug with existing INDs [125830, 138523, 138900], and the data from this study are intended to support a future U.S. marketing application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CVM-1118 in Combination with Sintilimab and TACE
| Arm | Type | Receives |
|---|---|---|
| CVM-1118 + Sintilimab + TACE | Experimental | Combination Product: CVM-1118 + Sintilimab + TACECVM-1118 (200 mg, PO, BID) + Sintilimab (200 mg, IV, Q3W) + TACE (4 times in maximum) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1) Participant is ≥18 years of age, at the time of providing the documented informed consent.
- 2) Diagnosis of hepatocellular carcinoma
- 3) No evidence of extrahepatic disease on any available imaging. 4) Disease not amenable to curative surgery or transplantation or curative ablation.
- 5) Disease must be amenable to TACE and anticipated to require no more than 4 TACE treatments for local disease sites, with a maximum of 2 TACE treatments per individual lesion .
- 6) Child-Pugh liver function class A (see Appendix 2). 7) At least one measurable (per RECIST 1.1) lesion (see Appendix 1). 8) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (see Appendix 3).
Key exclusion criteria (28 listed)
- 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 screening period.
- 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 agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T - lymphocyte - associated protein 4 [CTLA-4]).
- 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 HCC. Use of TACE or TAE as part of a curative therapy (e.g., in conjunction with ablation or surgery) can be acceptable if it is used in the lesions where curative therapy was attempted. However, TACE or TAE cannot have been used as sole modalities in prior curative therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVM-1118 + Sintilimab + TACECVM-1118 (200 mg, PO, BID) + Sintilimab (200 mg, IV, Q3W) + TACE (4 times in maximum) | Combination product | CVM-1118 + Sintilimab + TACE |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
13 secondary outcomes
Objective Response Rate (ORR)_mRECIST
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DoR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Time to progression (TTP)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Rate of Adverse event (AE) and Serious Adverse Event (SAE)
Time frame: Starting from the first dose of combination treatment until 28 days following the last dose of treatment by CTCAE v6.
Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Peak time(Tmax) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Half time(t1/2) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Clearance rate(CL) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Apparent volume of distribution(Vd) of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing
Time frame: During Cycle 1 (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 2
An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC
Hepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVM-1118 + Sintilimab + TACE in people with HCC - Hepatocellular Carcinoma, run by TaiRx, Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Man Chen (886-2-2653-5007, mandychen@trx.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.