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NCT Number: NCT07147101

Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

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Key information

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Peng MD, Wang

CONTACT

[email protected]

+86021-64041990

About this study

This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy, including anti-PD1+anti-VEGF, anti-PD1+TKI and anti-PD1+anti-CTLA4. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at time of study entry.
  • Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
  • HCC confirmed by radiology, histology or cytology.
  • No prior systemic therapy for HCC.
  • At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.
  • Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
  • Adequate organ function:
  • ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL.
  • Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).
  • Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.
  • Willing to provide archival/fresh tumor tissue and peripheral blood samples.
  • Signed informed consent.

Exclusion criteria

  • Prior systemic therapy for HCC
  • Active autoimmune disease requiring immunosuppression.
  • Active infection requiring IV antibiotics.
  • HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
  • Symptomatic CNS metastases.
  • Pregnancy/lactation.
  • Any condition compromising protocol compliance or data interpretation per investigator.

Treatment and study plan

Sintilimab

Drug

Sintilimab will be administered by IV, 200 mg every 3 weeks

Bevacizumab Biosimilar

Drug

Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.

Camrelizumab

Drug

Camrelizumab will be administered by IV, 200 mg every 2 weeks.

Rivoceranib

Drug

Rivoceranib will be administered by oral 250 mg once daily.

Nivolumab

Drug

Nivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks

Ipilimumab

Drug

Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.

Primary outcomes

  1. Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 24 months

    ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.

Secondary outcomes

  1. Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 24 months

    DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).

  2. Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 24 months

    DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.

  3. Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 24 months

    TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed.

  4. Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 24 months

    PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)

  5. Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

    Time frame: max 42 months

    OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death.

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: max 42 months

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.

  7. Translational study

    Time frame: max 24 months

    Proportion of different immune cell types in tumors and blood based on RNA sequencing between two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Wang, MD

CONTACT

[email protected]

86-21-64041990

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics

Acronym: HCC-IM-1

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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