NCT03239015

Efficacy and Safety of Precision Therapy in Refractory Tumor

Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Baodong Qin · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

Detailed description

The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without durgguable targets. The efficacy and safety of these regimens were evaluated.

Conditions

• Rare Tumor
• Refractory Tumor

Interventions

Type	Name	Description
DRUG	Gefitinib	Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUG	Erlotinib	Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUG	Afatinib	Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUG	Trastuzumab	Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
DRUG	Oxazolidine	Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
DRUG	Olaparib	Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
DRUG	Everolimus	Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
DRUG	Cabozantinib	Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
DRUG	Vemurafenib	Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
DRUG	Dabrafenib	Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
DRUG	Palbociclib	Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.
DRUG	PD-1/L1 inhibitor plus anti-angiogenic agent	PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2017-08-03
• Last updated: 2022-03-04

Locations

1 site across 1 country: China