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

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).

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Cancer
• Intervention / Treatment: Drug: Anlotinib;Toripalimab

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhengang Yuan, Ph.D; Phone Number: 00862181887451; Email: yuanzg@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200438
      • Recruiting
      • Eastern hepatobilliary surgery hospital
      • Contact: Wu Dong, MD; Phone Number: 0086-021-25070765; Email: wuyuz@yahoo.com.cn

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. 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;

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
Experimental: Anlotinib and Toripalimab treatment; Anlotinib Hydrochloride and Toripalimab Injection	Drug: Anlotinib;Toripalimab; Anlotinib Hydrochloride;Toripalimab injiection; Other Names: AL3818;JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Objective response rate include response from stable disease to complete	at least 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The time between the start of randomization and tumorigenesis or death	at least 2 months

Collaborators and Investigators

• Sponsor: Shen Feng

Study record dates

Study Major Dates

• Study Start (Anticipated): July 8, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Antotinib Toripalimab
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: EHBH-201908

Drug and device information, study documents

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