Efficacy and Safety of Precision Therapy in Refractory Tumor

Baodong Qin

Status and phase

Unknown

Phase 2

Conditions

Refractory Tumor

Rare Tumor

Treatments

Drug: Trastuzumab

Drug: Erlotinib

Drug: Everolimus

Drug: PD-1/L1 inhibitor plus anti-angiogenic agent

Drug: Afatinib

Drug: Dabrafenib

Drug: Olaparib

Drug: Oxazolidine

Drug: Cabozantinib

Drug: Palbociclib

Drug: Vemurafenib

Drug: Gefitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03239015

Long March Pathway

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

Targeted Drug Therapy Group

Experimental group

Description:

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.

Treatment: