TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis

NCT ID: NCT04888546

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2024-07-30

Brief Summary

In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy

Conditions

Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib hydrochloride capsules combined with TQB2450 injection

Anlotinib hydrochloride capsules (10mg po qd, Two weeks off for one week) combined with TQB2450 injection (1200mg ivgtt, q3W)

Group Type: OTHER

Anlotinib hydrochloride capsules＋ TQB2450 injection

Intervention Type: DRUG

Anlotinib hydrochloride capsules is a new type of small molecule multi-target tyrosine kinase inhibitor against angiogenesis.

TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.

Interventions

Anlotinib hydrochloride capsules＋ TQB2450 injection

Anlotinib hydrochloride capsules is a new type of small molecule multi-target tyrosine kinase inhibitor against angiogenesis.

TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary participation and written informed consent;

2. Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months;

3. No gender limitation;

4. Histologically confirmed hepatocellular carcinoma;

5. Meet resectable surgical criteria;

6. Child-Pugh:A or B;

7. According to RECIST 1.1, there is at least one evaluable lesion that has not been treated;

Exclusion Criteria

1. Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis;

2. Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy;

3. No radical resection could be performed after adequate imaging evaluation;

4. Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);

6. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hong Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hong Zhao, doctor

Role: primary

pumczhaohong@126.com

13381106850

Other Identifiers

TQB2450-Ib-13

Identifier Type: -

Identifier Source: org_study_id