Rare Tumor, Refractory Tumor
Conditions
Brief 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.
Interventions
DRUGGefitinib
Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUGErlotinib
Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUGAfatinib
Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
DRUGTrastuzumab
Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
DRUGOxazolidine
Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
DRUGOlaparib
Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
DRUGEverolimus
Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
DRUGCabozantinib
Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
DRUGVemurafenib
Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
DRUGDabrafenib
Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
DRUGPalbociclib
Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.
DRUGPD-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
Sponsors
Baodong Qin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months | Time from treatment beginning until death from any cause |
| Progress Free Survival | Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months | Time from treatment beginning until disease progression |
| Adverse Effect | Through study completion, an average of 1 months | Incidence of Treatment-related adverse Events |
Countries
China
Contacts
Primary ContactXiao-dong Jiao, MD.PHD
Outcome results
None listed