SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.

NCT06739317 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-HCC-II/III-030
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.

Conditions

Unresectable Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  The primary endpoint of phase 3 study is OS

  Up to approximately 3 years

• The R0 Resection rate of the experimental group

  The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group

  Up to approximately 30 days

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  Up to approximately 3 years

• Disease control rate (DCR)

  Up to approximately 3 years.

• Time to Response (TTR)

  Up to approximately 3 years.

• Duration of response (DoR)

  Up to approximately 3 years.

• Time to progression (TTP)

  Up to approximately 3 years.

Study Arms (2)

Experimental group

EXPERIMENTAL

Radiation: Radiation; Drug: First line therapy; Procedure: operation

control group

ACTIVE COMPARATOR

Drug: First line therapy

Interventions

Radiation RADIATION

Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.

Experimental group

First line therapy DRUG

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

control group

operation PROCEDURE

If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF).
• Aged 18 years or older.
• Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
• Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
• ECOG Performance Status of 0 or 1.
• Child-Pugh class of A.

You may not qualify if:

• Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
• Existence of active autoimmune disease or history of autoimmune disease and may relapse.
• Patients with innate or acquired immune deficiency (e.g., HIV infection).
• Known allergies to study drugs or excipients.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Radiation; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Ming Kuang

CONTACT

+86-020-87755766; kuangm@mail.sysu.edu.cn

Lixia Xu

CONTACT

+86-020-87755766

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)