Efficacy and Safety of Precision Therapy in Refractory Tumor

Sponsor
Baodong Qin
Study ID
NCT03239015
Phase
PHASE2
Status
Unknown

Conditions

  • Rare Tumor
  • Refractory Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2017
Status verified
Feb 2022
Primary completion
Jun 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Targeted Drug Therapy Group
    All recruited patients with druggable molecular event will be treated with corresponding targeted drug including Gefitinib/Erlotinib/Afatinib, Trastuzumab, Oxazolidine, Olaparib, Everolimus, Cabozantinib, Vemurafenib/Dabrafenib, and Palbociclib. If no durggable target, PD-1/L1 inhibitor plus anti-angiogenic agent was used.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months ]

Central Contacts