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

Phase 1

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

• Registration Number: NCT04888546
• Lead Sponsor: Chinese Academy of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.);

5. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The incidence and severity of AE	through study completion, an average of 1 year	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.
Progression free survival(PFS)	through study completion, an average of 1 year	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.
Overall survival (OS)	through study completion, an average of 1 year	It is defined as the time from randomization to death from any cause during the course of the study
The incidence and severity of SAE	through study completion, an average of 1 year	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).

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China