Advanced Hepatocellular Carcinoma (HCC)HCC-IM-1NCT07147101
Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment
An observational study of Advanced Hepatocellular Carcinoma (HCC), run by Fudan University at 1 site in China.
Trial summary
To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- Sintilimab, Bevacizumab Biosimilar and Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Observational
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
Study population: Patients with advanced hepatocellular carcinoma planed to receive first-line immunotherapy.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Peng MD, Wang, +86021-64041990, peng_wang@fudan.edu.cn
About this study
Official title: A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics
To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.
Read the detailed description
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.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- Sintilimab, Bevacizumab Biosimilar, Camrelizumab, Rivoceranib, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab will be administered by IV, 200 mg every 3 weeks
Bevacizumab BiosimilarDrug
Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
CamrelizumabDrug
Camrelizumab will be administered by IV, 200 mg every 2 weeks.
RivoceranibDrug
Rivoceranib will be administered by oral 250 mg once daily.
NivolumabDrug
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
IpilimumabDrug
Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.
| Study group | Role | What they receive |
|---|---|---|
| HCC cohort 1: Sintilimab plus bevacizumab biosimilar | Not described Receives: Drug: Sintilimab; Drug: Bevacizumab Biosimilar | |
| HCC cohort 2: Camrelizumab plus Rivoceranib | Not described Receives: Drug: Camrelizumab; Drug: Rivoceranib | |
| HCC cohort 3: O+Y | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Measured: max 24 months
Secondary outcomes (7)
Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).
Measured: max 24 months
Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Measured: max 24 months
Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
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.
Measured: max 24 months
Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)
Measured: max 24 months
Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death.
Measured: max 42 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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.
Measured: max 42 months
Translational study
Proportion of different immune cell types in tumors and blood based on RNA sequencing between two groups.
Measured: max 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147101
- Sponsor's protocol ID
- HCC-IM-1
- Acronym
- HCC-IM-1
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No