NCT04777162

Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

Efficacy and Safety of Tislelizumab Plus Anlotinib in PD-1/PD-L1 Resistant Metastatic Gastric or Colorectal Cancer: a Single Arm Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy acquired resistance was observed in clinical practice. The investigators intended to add anlotinib to PD-1 inhibitors, hoping reverse the resistance.

Detailed description

Anti-angiogenesis seems have positive effects on tumor immune microenvironment. the combination of PD-1/PD-L1 inhibitors and TKIs exhibited favorable efficacy on gastrointestinal malignancies. Here the investigators want to examine the efficacy and survival benefit from the combination therapy to PD-1 acquired resistance patients, which turns out to be critical issues in recent years.

Conditions

• Gastric Cancer
• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	For included participants, tislelizumab would be administrated 200mg q3w iv.
DRUG	Anlotinib	Patients will be administrated with Anlotinib 12mg p.o. d1-d14 q3w.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-01-01
• Completion: 2023-05-01
• First posted: 2021-03-02
• Last updated: 2021-03-04

Locations

1 site across 1 country: China