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

Hepatocellular Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453383
• Other study ID #: EHBH-201908
• Status: Recruiting
• Phase: Phase 2
• Start date: July 8, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Zhengang Yuan, Ph.D
• Phone: 00862181887451
• Email: yuanzg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Liver Neoplasms

Intervention

Drug:
• Anlotinib;Toripalimab
Anlotinib Hydrochloride;Toripalimab injiection

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shen Feng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate include response from stable disease to complete	at least 2 months
Secondary	Progression-free survival	The time between the start of randomization and tumorigenesis or death	at least 2 months