Efficacy and Safety of Precision Therapy in Refractory Tumor

Refractory Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03239015
• Other study ID #: Long March Pathway
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Shanghai Changzheng Hospital
• Contact: Xiao-dong Jiao, MD.PHD
• Phone: +86-13817797639
• Email: pulava[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Neoplasms
• Rare Tumor
• Refractory Tumor

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baodong Qin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Secondary	Progress Free Survival	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Secondary	Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Secondary	Adverse Effect	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months