NCT06796803

Brief Summary

The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for phase_2

Timeline
46mo left

Started Feb 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Feb 2025Feb 2030

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

February 10, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

January 22, 2025

Last Update Submit

February 6, 2025

Conditions

Potentially Resectable Hepatocellular Carcinoma

Keywords

conversion therapyhepatocellular carcinomacamrelizumab and rivoceranib

Outcome Measures

Primary Outcomes (2)

  • R0 rate

    R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin

    24 months

  • OS

    Overall survival (OS) after randomization, defined as the time from randomization to death from any cause

    24 months

Secondary Outcomes (6)

  • EFS

    24 months

  • ORR

    24 months

  • DCR

    24 months

  • pCR rate

    24 months

  • MPR rate

    24 months

  • +1 more secondary outcomes

Study Arms (2)

camrelizumab + rivoceranib + HAIC

EXPERIMENTAL
Drug: camrelizumab combined with rivoceranib and HAIC

camrelizumab + rivoceranib

ACTIVE COMPARATOR
Drug: camerlizumab + rivoceranib

Interventions

camrelizumab combined with rivoceranib and HAICDRUG

systemic therapy combined with locoregional theraphy as conversion therapy

camrelizumab + rivoceranib + HAIC
camerlizumab + rivoceranibDRUG

systemic therapy

camrelizumab + rivoceranib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form (ICF)
  • Aged ≥18 years and ≤75 years at time of signing ICF
  • Documented diagnosis of HCC confirmed by histology/cytology or clinically
  • Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
  • At least one measurable lesion (per RECIST v1.1) untreated lesion
  • ECOG performance status of 0 or 1
  • Child-Pugh ≤7 score
  • Life expectancy ≥12 weeks
  • Adequate organ function
  • No prior anti-tumor systemic therapies for HCC

You may not qualify if:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Other active malignant tumor except HCC within 5 years or simultaneously
  • Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
  • There is an absolute contraindication to HAIC
  • History of hepatic encephalopathy
  • Diffuse HCC, intrahepatic tumor burden \> 50%
  • PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
  • Clinically significant ascites
  • Prior allogeneic stem cell or solid organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Huichuan Sun, MD, PHD

CONTACT

sun.huichuan@zs-hospital.sh.cnsun.huichuan@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

February 20, 2025

Primary Completion (Estimated)

February 20, 2028

Study Completion (Estimated)

February 28, 2030

Last Updated

February 10, 2025

Record last verified: 2025-01

Locations

CN(1)