Efficacy and Safety of Precision Therapy in Refractory Tumor

NCT ID: NCT03239015

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Rare Tumor; Refractory Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gefitinib

Intervention Type: DRUG

Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Erlotinib

Intervention Type: DRUG

Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Afatinib

Intervention Type: DRUG

Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Trastuzumab

Intervention Type: DRUG

Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.

Oxazolidine

Intervention Type: DRUG

Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.

Olaparib

Intervention Type: DRUG

Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.

Everolimus

Intervention Type: DRUG

Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.

Cabozantinib

Intervention Type: DRUG

Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.

Vemurafenib

Intervention Type: DRUG

Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

Dabrafenib

Intervention Type: DRUG

Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

Palbociclib

Intervention Type: 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

Intervention Type: DRUG

PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target

Interventions

Gefitinib

Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Intervention Type: DRUG

Erlotinib

Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Intervention Type: DRUG

Afatinib

Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.

Intervention Type: DRUG

Trastuzumab

Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.

Intervention Type: DRUG

Oxazolidine

Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.

Intervention Type: DRUG

Olaparib

Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.

Intervention Type: DRUG

Everolimus

Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.

Intervention Type: DRUG

Cabozantinib

Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.

Intervention Type: DRUG

Vemurafenib

Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

Intervention Type: DRUG

Dabrafenib

Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.

Intervention Type: DRUG

Palbociclib

Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baodong Qin

OTHER

Sponsor Role: lead

Responsible Party

Baodong Qin

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yuan-Sheng Zang, MD.PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao-dong Jiao, MD.PHD

Role: CONTACT

pulava@163.com

+86-13817797639

Facility Contacts

Xiao-Dong Jiao, MD

Role: primary

pulava@139.com

+86-13817797639

References

Qin BD, Jiao XD, Wang Z, Liu K, Wu Y, Ling Y, Chen SQ, Zhong X, Duan XP, Qin WX, Xue L, Guo ZH, Zang YS. Pan-cancer efficacy and safety of anlotinib plus PD-1 inhibitor in refractory solid tumor: A single-arm, open-label, phase II trial. Int J Cancer. 2023 Aug 15;153(4):815-825. doi: 10.1002/ijc.34546. Epub 2023 May 8.

Reference Type: DERIVED

PMID: 37155342 (View on PubMed)

Jiao XD, Qin BD, Wang Z, Liu K, Wu Y, Ling Y, Qin WX, Wang MM, Yuan LY, Barreto SG, Kim AW, Mak K, Li H, Xu YY, Qiu XM, Wu M, Jin M, Xu LC, Zhong Y, Yang H, Chen XQ, Zeng Y, Shi J, Zhu WY, Ding QQ, Jia W, Liu SF, Zhou JJ, Shen H, Yao SH, Guo ZJ, Li T, Zhou PJ, Dong XW, Lu WF, Coleman RL, Akce M, Akladios C, Puccetti F, Zang YS. Targeted therapy for intractable cancer on the basis of molecular profiles: An open-label, phase II basket trial (Long March Pathway). Front Oncol. 2023 Feb 23;13:860711. doi: 10.3389/fonc.2023.860711. eCollection 2023.

Reference Type: DERIVED

PMID: 36910668 (View on PubMed)

Other Identifiers

Long March Pathway

Identifier Type: -

Identifier Source: org_study_id