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Clinical Recruitment of Patients With First-line Targeted Drug Resistance or Intolerance to Hepatocellular Cancer With PD-1 Inhibitor (Toripalimab,JS001) Detected on the NGS Platform Combined With Anlotinib

Primary Purpose

Hepatocellular Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib;Toripalimab

About this trial

This is an interventional treatment trial for Hepatocellular Cancer focused on measuring Antotinib Toripalimab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or cytological diagnosis of hepatocellular cancer;
At least one measurable lesion was assessed according to RECIST1.1 criteria.
Age from 18 to 75,ECOG physical strength score reaches 0-2;
After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria.
Child-pugh grade A or B for liver function;
Bone marrow function was basically normal: neutrophils > 1.5x 10^9/L, platelets > 75 x10^9/L;
Adequate renal reserve: creatinine <130 mol/L;
Centerless dysfunction, chest pain (medically uncontrollable), no myocardial infarction within 12 months prior to study initiation;
Estimated survival ≥3 months;
Signed the informed consent.

Exclusion Criteria:

Previous application of PD-1 inhibitor and anlotinib;
Secondary malignant tumors or other tumors (except superficial skin cancer and localized low-grade malignant tumors) occurring within 3 years prior to the start of the study;
Metastasis of the brain or meninges;
Imaging findings indicated that the tumor was involved in important blood vessels or that the researchers had assessed that it might lead to fatal bleeding during follow-up;
Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures;
The time of occurrence of arteriovenous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 6 months before enrollment;
Untreated intestinal obstruction or subobstruction that cannot eat or affect systemic administration;
Patients with active infection or other possible disorders receive inflammatory infections under planned management;
Have a history of uncontrolled substance abuse or mental disorders;
In the judgment of the investigator, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study;
Participated in other clinical trials;
Pregnant and nursing women;

Sites / Locations

Eastern hepatobilliary surgery hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib and Toripalimab treatment

Arm Description

Anlotinib Hydrochloride and Toripalimab Injection

Outcomes

Primary Outcome Measures

Objective response rate

Objective response rate include response from stable disease to complete

Secondary Outcome Measures

Progression-free survival

The time between the start of randomization and tumorigenesis or death

Full Information

NCT ID

NCT05453383

First Posted

July 7, 2022

Last Updated

July 7, 2022

Sponsor

Shen Feng

1. Study Identification

Unique Protocol Identification Number

NCT05453383

Brief Title

Clinical Recruitment of Patients With First-line Targeted Drug Resistance or Intolerance to Hepatocellular Cancer With PD-1 Inhibitor (Toripalimab,JS001) Detected on the NGS Platform Combined With Anlotinib

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shen Feng

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

PD-1 inhibitors have become the standard treatment for advanced hepatocellular cancer, while targeted drugs such as sorafenib and lenvatinib are the first-line standard treatment for hepatocellular cancer. Recent studies have shown that PD-1 inhibitors combined with targeted drugs can improve the efficacy of hepatocellular cancer.To clear the joint treatment in patients with advanced hepatocellular cancer (HCC) efficacy and evaluate its safety, we proposed to carry out the PD - 1 inhibitor (Toripalimab, JS001) joint anti-angiogenesis small molecules targeting drug anlotinib for clinical research,at the same time, based on joint solution of NGS platform testing to predict the curative effect, bring benefit for the long-term survival of patients with hepatocellular cancer (HCC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Cancer

Keywords

Antotinib Toripalimab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anlotinib and Toripalimab treatment

Arm Type

Experimental

Arm Description

Anlotinib Hydrochloride and Toripalimab Injection

Intervention Type

Drug

Intervention Name(s)

Anlotinib;Toripalimab

Other Intervention Name(s)

AL3818;JS001

Intervention Description

Anlotinib Hydrochloride;Toripalimab injiection

Primary Outcome Measure Information:

Title

Objective response rate

Description

Objective response rate include response from stable disease to complete

Time Frame

at least 2 months

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

The time between the start of randomization and tumorigenesis or death

Time Frame

at least 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of hepatocellular cancer; At least one measurable lesion was assessed according to RECIST1.1 criteria. Age from 18 to 75,ECOG physical strength score reaches 0-2; After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria. Child-pugh grade A or B for liver function; Bone marrow function was basically normal: neutrophils > 1.5x 10^9/L, platelets > 75 x10^9/L; Adequate renal reserve: creatinine <130 mol/L; Centerless dysfunction, chest pain (medically uncontrollable), no myocardial infarction within 12 months prior to study initiation; Estimated survival ≥3 months; Signed the informed consent. Exclusion Criteria: Previous application of PD-1 inhibitor and anlotinib; Secondary malignant tumors or other tumors (except superficial skin cancer and localized low-grade malignant tumors) occurring within 3 years prior to the start of the study; Metastasis of the brain or meninges; Imaging findings indicated that the tumor was involved in important blood vessels or that the researchers had assessed that it might lead to fatal bleeding during follow-up; Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures; The time of occurrence of arteriovenous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 6 months before enrollment; Untreated intestinal obstruction or subobstruction that cannot eat or affect systemic administration; Patients with active infection or other possible disorders receive inflammatory infections under planned management; Have a history of uncontrolled substance abuse or mental disorders; In the judgment of the investigator, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study; Participated in other clinical trials; Pregnant and nursing women;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhengang Yuan, Ph.D

Phone

00862181887451

yuanzg@163.com

Facility Information:

Facility Name

Eastern hepatobilliary surgery hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200438

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shen Feng, MD

Phone

0086-021-25070805

shenfengdfgd@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Wu Dong, MD

Phone

0086-021-25070765

wuyuz@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Shen Feng, MD

12. IPD Sharing Statement

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