Efficacy and Safety of Precision Therapy in Refractory Tumor

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    300
  • sponsor
    Baodong Qin
Updated on 8 March 2022

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.

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.

Details
Condition Rare Tumor, Refractory Tumor
Treatment Everolimus, Trastuzumab, Afatinib, Erlotinib, Gefitinib, olaparib, Vemurafenib, Palbociclib, Cabozantinib, Dabrafenib, Oxazolidine, PD-1/L1 inhibitor plus anti-angiogenic agent
Clinical Study IdentifierNCT03239015
SponsorBaodong Qin
Last Modified on8 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Malignant solid tumors diagnosed histologically
Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment
Expected survival ≥ 1 month
ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria

Patient still has standard treatment therapy based on NCCN guidance
Patient can not comply with research program requirements or follow-up
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