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

• Sponsor: Shen Feng (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05453383
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.8
• Patients Per Site Per Month: 5.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer	Drug: Anlotinib;Toripalimab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Jul 8, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anlotinib and Toripalimab treatment Anlotinib Hydrochloride and Toripalimab Injection	Drug: Anlotinib;Toripalimab; Anlotinib Hydrochloride;Toripalimab injiection; Other Names: AL3818;JS001

Outcome Measures

Primary Outcome Measures

1. Objective response rate [at least 2 months]

   Objective response rate include response from stable disease to complete

Secondary Outcome Measures

1. Progression-free survival [at least 2 months]

   The time between the start of randomization and tumorigenesis or death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai	China	200438

Sponsors and Collaborators

• Shen Feng

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shen Feng, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital
• ClinicalTrials.gov Identifier: NCT05453383
• Other Study ID Numbers: EHBH-201908
• First Posted: Jul 12, 2022
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shen Feng, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital: Antotinib Toripalimab
• Additional relevant MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jul 12, 2022