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

A Single-arm, Multicenter Phase Ib Clinical Trial of the Efficacy and Safety of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Neoadjuvant in the Treatment of Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis

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

Study Overview

• Status: Recruiting
• Conditions: Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi
• Intervention / Treatment: Drug: Anlotinib hydrochloride capsules＋ TQB2450 injection

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Chinese Academy of Medical Sciences
      • Contact: Hong Zhao, doctor; Phone Number: 13381106850; Email: pumczhaohong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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)

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological complete response rate (pCR)	No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.	6 months
Overall response rate (ORR)	Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 .	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival(PFS)	Disease control rate refers to the percentage of subjects with a disease stabilization (SD) of 6 weeks or greater in complete response, partial response, or at least 6 weeks, as determined by RECIST 1.1.	through study completion, an average of 1 year
Overall survival (OS)	It is defined as the time from randomization to death from any cause during the course of the study	through study completion, an average of 1 year
The incidence and severity of AE	AE is any adverse medical event that occurs in a subject participating in a clinical trial that may or may not have a causal relationship with the treatment.An AE can be any adverse and unexpected signs (including abnormal laboratory results), symptoms, or diseases that are time-related to the use of the study drug, whether or not the study drug is considered relevant.	through study completion, an average of 1 year
The incidence and severity of SAE	When subjects were tested with drug adverse events of comply with the following one or more than a standard as a serious adverse event (SAE) : death, life-threatening, permanent or severe disability or loss of function, subjects requiring hospitalization or extend the length of hospital stay, congenital anomaly, or birth defects, subsequent pregnancy happen (natural or artificial abortion, the pregnancy is terminated because of medical reasons) and other important medical event (no threat to life or death, but may endanger patients or may lead to interventions are needed to prevent this happen).	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Anticipated): July 30, 2024
• Study Completion (Anticipated): July 30, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: TQB2450-Ib-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No