Adebrelimab + Apatinib in Advanced HCC Post-Systemic Therapy

NCT07192848 | Not Yet Recruiting Phase 2

• 1 other identifier: YW2025-17-1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who progressed after prior systemic therapy (targeted ± immunotherapy) are enrolled. Primary endpoint: objective response rate (ORR). Planned enrollment: 47 subjects. Eligible patients receive adebrelimab + apatinib. After informed consent and screening, treatment starts: Adebrelimab 1200mg IV on D1, Q3W; apatinib 250mg oral QD, continuous. 21-day cycle. Treatment continues until intolerable toxicity, consent withdrawal, RECIST v1.1-proven progression (may continue if clinically beneficial), or protocol-specified criteria (whichever first). Safety follow-up on D1 of each cycle; imaging every 2 cycles (6-8 weeks) for efficacy. Post-treatment: continued safety and survival follow-up.

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Adebrelimab; Apatinib; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR): It refers to the percentage of subjects who achieve complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1, mRECIST, or imRECIST (for CR and PR under the imRECIST criteria, they can occur after radiographic disease progression).

  up to one year

Secondary Outcomes (7)

• Median Progression-free survival

  up to one year

• Time to Progression (TTP)

  up to one year

• Disease Control Rate (DCR)

  up to one year

• Duration of Response (DOR)

  up to one year

• Overall Survival (OS)

  up to one year

Study Arms (1)

Adebrelimab + Apatinib Treatment Arm

EXPERIMENTAL

This arm involves patients receiving adebrelimab (1200mg, intravenous infusion on D1, Q3W) combined with apatinib (250mg, oral, QD). Treatment continues until intolerable toxicity, withdrawal of consent, disease progression, or other protocol - defined criteria.

Drug: Adebrelimab + Apatinib

Interventions

Adebrelimab + Apatinib DRUG

Adebrelimab: A fixed dose of 1200 mg is administered as an intravenous infusion over 30 minutes (not less than 20 minutes and not more than 60 minutes, including the flushing phase), once every 3 weeks (Q3W). The interval between two administrations should not be less than 12 days. The maximum treatment duration is 6 courses. Apatinib: 250 mg, once daily (QD), taken orally within half an hour after a meal, continuously, with a 3 - week (21 - day) cycle. The maximum treatment duration is 6 courses.

Adebrelimab + Apatinib Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participate in this study and sign the informed consent form;
• Aged ≥ 18 years (calculated as of the date of signing the informed consent form), male or female;
• Pathologically or clinically confirmed hepatocellular carcinoma (HCC);
• Have previously received at least one or more lines of systemic therapy (targeted therapy with or without immunotherapy);
• Barcelona Clinic Liver Cancer (BCLC) stage B or C, unsuitable for surgery or local treatment, or progressed after surgery and/or local treatment;
• Local treatment (including but not limited to surgery, radiotherapy, hepatic artery embolization, transcatheter arterial chemoembolization \[TACE\], hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks before the baseline imaging scan (palliative radiotherapy requires only 2 weeks), and toxic reactions caused by local treatment (except alopecia) must have recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0);
• Presence of measurable lesions meeting the modified Response Evaluation Criteria in Solid Tumors (mRECIST) on baseline imaging;
• Child-Pugh liver function class A;
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1;
• Expected survival time \> 3 months;
• Basic normal function of major organs, without severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases, meeting the protocol requirements:
• Blood routine examination: (except hemoglobin; no blood transfusion, no use of granulocyte colony-stimulating factor \[G-CSF\] within 14 days before screening, and no corrective treatment within 7 days) i. Hemoglobin ≥ 90 g/L; ii. Neutrophil count ≥ 1.5×10\^9/L; iii. Platelet count ≥ 50×10\^9/L;
• Biochemical examination: (no albumin transfusion within 14 days) i. Serum albumin ≥ 29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); iii. Total bilirubin (TBIL) ≤ 1.5×ULN; iv. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance \> 50 mL/min (calculated using the Cockcroft-Gault formula as follows): For males: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr) For females: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr) × 0.85 (Weight unit: kg; Serum Cr unit: mg/mL) v. Urinary protein \< 2+; if urinary protein ≥ 2+, a 24-hour urinary protein quantification can be performed, and patients with 24-hour urinary protein quantification \< 1.0 g are eligible for enrollment;
• Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN (patients receiving stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants can be screened);
• Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, triiodothyronine (T3) and thyroxine (T4) levels should be examined, and patients with normal T3 and T4 levels are eligible;

You may not qualify if:

• Previously received PD-L1 immunotherapy or apatinib targeted therapy;
• No clear tumor-feeding artery identifiable by angiography;
• Known cholangiocellular carcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; having other active malignant tumors (except HCC) within 5 years or concurrently. Locally cured tumors such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment;
• Allergic to the investigational drugs;
• Complicated with other malignant tumors, except for the following cases: malignant tumors treated with curative therapy, with no known active disease for ≥ 5 years before the first study intervention and low potential risk of recurrence; basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, or lentigo maligna with potentially radical treatment; or carcinoma in situ with adequate treatment and no evidence of disease;
• A history of hepatic encephalopathy;
• Received other investigational drug treatments within 28 days or 5 half-lives (whichever is longer) before the start of study treatment;
• Complicated with severe infection;
• Any evidence of disease as judged by the investigator (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active hemorrhagic diseases, active infections, active interstitial lung disease/pulmonary inflammation, severe chronic gastrointestinal diseases related to diarrhea, mental illness/social conditions) or a history of allogeneic organ transplantation that the investigator considers makes the subject unfit to participate in the study or affects compliance with the study protocol;
• Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel diseases \[e.g., colitis or Crohn's disease\], diverticulitis \[excluding diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc.);
• Known positive HIV test (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical assessment may include clinical history, physical examination, and imaging findings, or tuberculosis testing according to local practices).

Sponsors & Collaborators

• Song Peng: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Shenzhen, Guangdong, 518116, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

peng song, MD

CONTACT

+86-400 13811240481; songpeng@cicams-sz.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)