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

NCT ID: NCT06739317

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2031-06-30

Brief Summary

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•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.

Detailed Description

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Conditions

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Unresectable Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

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

First line therapy

Intervention Type DRUG

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

operation

Intervention Type PROCEDURE

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

control group

Group Type ACTIVE_COMPARATOR

First line therapy

Intervention Type DRUG

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

Interventions

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Radiation

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

Intervention Type RADIATION

First line therapy

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

Intervention Type DRUG

First line therapy

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

Intervention Type DRUG

operation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming Kuang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Ming Kuang

Role: CONTACT

Phone: +86-020-87755766

Email: [email protected]

Lixia Xu

Role: CONTACT

Phone: +86-020-87755766

Facility Contacts

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Ming Kuang

Role: primary

Other Identifiers

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MA-HCC-II/III-030

Identifier Type: -

Identifier Source: org_study_id