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

NCT ID: NCT05453383

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2022-12-31

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).

Conditions

Hepatocellular Cancer

Study Design

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

Study Groups

Anlotinib and Toripalimab treatment

Anlotinib Hydrochloride and Toripalimab Injection

Group Type: EXPERIMENTAL

Anlotinib;Toripalimab

Intervention Type: DRUG

Anlotinib Hydrochloride;Toripalimab injiection

Interventions

Anlotinib;Toripalimab

Anlotinib Hydrochloride;Toripalimab injiection

Intervention Type: DRUG

Other Intervention Names

AL3818;JS001

Eligibility Criteria

Inclusion Criteria

1. Histological or cytological diagnosis of hepatocellular cancer;

2. At least one measurable lesion was assessed according to RECIST1.1 criteria.

3. Age from 18 to 75,ECOG physical strength score reaches 0-2;

4. After first-line targeted therapy, it was assessed as advanced or intolerant according to RECIST1.1 criteria.

5. Child-pugh grade A or B for liver function;

6. Bone marrow function was basically normal: neutrophils > 1.5x 10^9/L, platelets > 75 x10^9/L;

7. Adequate renal reserve: creatinine <130 mol/L;

8. Centerless dysfunction, chest pain (medically uncontrollable), no myocardial infarction within 12 months prior to study initiation;

9. Estimated survival ≥3 months;

10. Signed the informed consent.

Exclusion Criteria

1. Previous application of PD-1 inhibitor and anlotinib;

2. 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;

3. Metastasis of the brain or meninges;

4. 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;

5. Bleeding events at any site ≥CTCAE level 3 occurred 4 weeks before medication, and there were unhealed wounds, ulcers or fractures;

6. The time of occurrence of arteriovenous thrombosis, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism, within 6 months before enrollment;

7. Untreated intestinal obstruction or subobstruction that cannot eat or affect systemic administration;

8. Patients with active infection or other possible disorders receive inflammatory infections under planned management;

9. Have a history of uncontrolled substance abuse or mental disorders;

10. 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;

11. Participated in other clinical trials;

12. Pregnant and nursing women;

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

Sponsors

Shen Feng

OTHER

Sponsor Role: lead

Responsible Party

Shen Feng

Director of Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengang Yuan, Ph.D

Role: CONTACT

yuanzg@163.com

00862181887451

Facility Contacts

Shen Feng, MD

Role: primary

shenfengdfgd@yahoo.com.cn

0086-021-25070805

Wu Dong, MD

Role: backup

wuyuz@yahoo.com.cn

0086-021-25070765

Other Identifiers

EHBH-201908

Identifier Type: -

Identifier Source: org_study_id