HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure

NCT06375317 | Not Yet Recruiting Phase 2

• 1 other identifier: HCC-HAIC-001
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  approximately 1years

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  Up to approximately 1 years

• Progression-Free Survival (PFS)

  approximately 2 years

• Overall Survival (OS)

  approximately 2 years

Study Arms (1)

HAIC Combined with PD-L1 Plus Regorafenib

EXPERIMENTAL

Drug: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets

Interventions

PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets DRUG

PD-L1 injection: 20 mg/kg, administered every 3 weeks (Q3W). Regorafenib: 80 mg, orally, once daily (qd), continuously for 14 days per cycle, followed by a 7-day rest period, administered every 3 weeks (Q3W). FOLFOX regimen: Oxaliplatin 85 mg/m2, Calcium folinate 400 mg/m2, Fluorouracil 400 mg/m2 as an IV bolus, followed by Fluorouracil 1200 mg/m2 infusion over 23 hours, administered every 3 weeks (Q3W) for a total of 6 cycles. The above doses are recommended doses.

HAIC Combined with PD-L1 Plus Regorafenib

Eligibility Criteria

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

You may qualify if:

• Advanced HCC confirmed by imaging or histopathological examination based on biopsy specimens and/or surgical pathology;
• Patients who have failed ≥1 line of PD-1/PD-L1 immune checkpoint inhibitor therapy;
• Imaging diagnosis with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1);
• Expected survival period ≥3 months;
• ECOG performance status of 0-1;
• Child-Pugh score of grade A (i.e., a score of 5 to 6);
• Adequate organ and bone marrow function;
• Male participants and women of childbearing potential must use contraception from the start of the first dose to 3 months after the last dose;
• Expected good compliance and ability to comply with the study requirements.

You may not qualify if:

• Previous history of immunotherapy with any of the following:
• Any grade 3 or higher immune-related adverse events (irAEs);
• Any unresolved grade 2 irAEs;
• Any toxicity resulting in permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy;
• Patients assessed as having progressed within ≤3 months during prior immunotherapy.
• Previous treatment with Regorafenib;
• Known allergy to the study drug or any of its excipients;
• Received any of the following treatments or medications prior to the first study treatment:
• Major surgery within 28 days prior to treatment initiation (diagnostic tissue biopsy is allowed).
• Use of immunosuppressive medications within 7 days prior to treatment initiation, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or its equivalent).
• Receipt of immunomodulatory drugs (such as thymosin, interferon, interleukins) within 3 weeks prior to treatment initiation.
• Receipt of attenuated live vaccines within 28 days prior to treatment initiation.
• Receipt of other systemic anticancer therapy within 28 days prior to treatment initiation.
• Known uncontrollable or symptomatic active central nervous system (CNS) metastases;
• Diagnosis of other active malignancies within 2 years prior to study entry, except for locally treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer.

Sponsors & Collaborators

• Yehua Shen: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Shen ye Hua, Ph.D

CONTACT

02164175590; syh@163.com

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: Professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04