A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

NCT05975645 | Terminated Phase 1

• 1 other identifier: TQB2618-AK105-Ib-04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 8

Brief Summary

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib Hydrochloride Capsules in patients with advanced HCC.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Percentage of subjects achieving complete response (CR) and partial response (PR).

  Up to 2 years.

Secondary Outcomes (9)

• Overall Survival (OS)

  Up to two and a half years.

• Progress Free Survival (PFS)

  Up to 2 years.

• Disease Control Rate (DCR)

  Up to 2 years.

• Duration of Response (DOR)

  Up to 2 years.

• Incidence of Anti-Drug antibody (ADA)

  Before administration on the first day of the 1st, 2nd, 4th, and 8th cycles, 30 days and 90 days after the last administration. Each cycle is 21 days.

Study Arms (1)

TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules

EXPERIMENTAL

Intravenous infusion of TQB2618 Injection 1200mg and Penpulimab Injection 200mg on 1st day, combining with Anlotinib capsules 10mg given orally in fasting conditions once daily in each 21-day cycle. (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Drug: Penpulimab injection; Drug: TQB2618 injection; Drug: Anlotinib Hydrochloride Capsules

Interventions

Penpulimab injection DRUG

Penpulimab is an inhibitor of programmed cell death 1 (PD-1).

TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules

TQB2618 injection DRUG

TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3).

TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules

Anlotinib Hydrochloride Capsules DRUG

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

TQB2618 injection +Penpulimab injection+ Anlotinib Hydrochloride Capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
• Patients with HCC diagnosed by histopathological or cytological examination or in line with clinical diagnostic criteria.
• No systematic treatment for advanced HCC has been received before.
• China liver cancer staging (CNLC)stage III or Barcelona Clinic Liver Cancer (BCLC) stage C, or CNLC stage II (BCLC B) subjects who are not suitable for local treatment and surgical treatment, or who are judged by researchers to be unable to benefit from local treatment and surgical treatment.
• Liver function score was good.
• Hepatitis B surface antigen (HBsAg) positive patients must meet hepatitis B virus deoxyribonucleic acid (HBV DNA) quantification \< 10000 IU / ml (or 50000 copy/ml), and anti-HBV therapy should be given for at least 1 week before the first administration; investigator needs to determine that hepatitis C virus (HCV) infection is in a stable state.
• Patients after local treatment should be administered at least 4 weeks after the end of local treatment and have fully recovered from treatment toxicity and/or complications.
• Radiotherapy for bone metastases accompanied by clinical symptoms must be completed at least 2 weeks before the first administration.
• Has at least one measurable lesion.
• The Main organ function is normal.
• Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotropin (HCG) test is not negative within 7 days before the first administration and must be non-lactating patients.
• Voluntary and signed informed consent, good compliance.

You may not qualify if:

• Combined disease and medical history :
• Other malignant tumors had appeared or were suffering from at the same time within 3 years before the first administration.
• Unrelieved toxic reactions higher than grade 1 due to any previous treatment.
• Major surgical treatment, obvious traumatic injury, or long-term unhealed wounds or fractures were received within 28 days before the first administration.
• Patients who had any bleeding or bleeding events ≥grade 3 within 8 weeks before the first administration, or had arterial/venous thrombosis events within 6 months before the first administration.
• There was a history of gastrointestinal bleeding within 6 months before the first administration; other conditions that may cause gastrointestinal bleeding or perforation.
• Patients with portal hypertension have a high risk of bleeding, or gastroscopy confirmed red sign or severe esophageal and gastric varices.
• Active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or active pneumonia with clinical symptoms.
• Have a history of mental drug abuse that cannot be withdrawn, or have a mental disorder.
• Patients who had previously received or planned to receive allogeneic bone marrow transplantation or solid organ transplantation within 6 months.
• Have a history of hepatic encephalopathy.
• Currently using or recently used aspirin (\>325mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol treatment.
• Have any heavy and/or uncontrolled disease.
• Tumor-related, previous, and current treatment:
• Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc. Clinically considered as hepatobiliary mixed tumor.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (8)

Gansu Wuwei Cancer Hospital

Wuwei, Gansu, 733099, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510600, China

Location

Affiliated hospital of zunyi medical university

Zunyi, Guizhou, 563099, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The First People's Hospital of Shangqiu City

Shangqiu, Henan, 476100, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

The six people's Hospital of Shenyang

Shenyang, Liaoning, 110000, China

Location

Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

penpulimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 15, 2023
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-06

Locations

CN (8)