Anlotinib and TQB2450 in Advanced Hepatocellular Carcinoma After Failure of Prior Immune Checkpoint Inhibitors

NCT06031480 | Unknown Phase 2

• 1 other identifier: KY2023297
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is an multi-center, single arm, exploratory study to evaluate the efficacy and safety of anlitinib combined with TQB2450 in patients with advanced hepatocellular carcinoma （HCC）who failed prior immune checkpoint inhibitor therapies.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR, RECIST v1.1)

  ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs

  24 months

Study Arms (1)

anlotinib+TQB2450

EXPERIMENTAL

Drug: Anlotinib and TQB2450

Interventions

Anlotinib and TQB2450 DRUG

Anlotinib: 10mg PO, QD, D1-14, Q3W; TQB2450: 1200 mg, IV, D1, Q3W. Anlotinib and TQB2450 will be administered until the disease progression, intolerable toxicity, death, withdrawal of consent.

anlotinib+TQB2450

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants must be required to sign an informed consent
• Hepatocellular carcinoma patients confirmed by pathological or cytological examination, or who meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of primary hepatocellular carcinoma" (2022)
• At least one measurable lesion (RECIST 1.1)
• Chinese Liver Cancer Staging (CNLC): CNLC-IIa, IIb, IIIa, IIIb (BCLC-B and C) that are not suitable for local treatment (TACE, HAIC, etc.) or that have progressed after local treatment
• The previous treatment plan for patients before enrollment was a standard treatment plan containing immune checkpoint inhibitors, and patients with progression or intolerance were evaluated based on the RECIST v1.1 standard
• Child-Pugh Score, Class A or better B
• ECOG performance status 0 or 1
• Adequate organ function
• Life expectancy of at least 3 months

You may not qualify if:

• Patients who have received local treatment (including TACE, ablation, HAIC, radiotherapy) and are less than 1 month after enrollment
• Patients who have received ≥ 2 treatments with immune checkpoint inhibitor regimens
• Adverse events above level 1(NCI-CTCAE v5.0) caused by any previous treatment that have not returned to ≤ level 1 (excluding hair loss); Patients with previous severe immune-related AEs requiring permanent cessation of immunotherapy
• Pregnant or lactating wome

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Zhongshan hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

anlotinib

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

Study Officials

• Jia Fan

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinghao Shen

CONTACT

0086-13916276098; shen.yinghao@zs-hospital.sh.cn

Huichuan Sun

CONTACT

0086-13701922065; sun.huichuan@zs-hospital.sh.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

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: October 31, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-07

Locations

CN (1)