Efficacy and Safety of Precision Therapy in Refractory Tumor
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 4, 2022
February 1, 2022
6.5 years
July 28, 2017
February 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Progress Free Survival
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Overall Survival
From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Through study completion, an average of 1 months
Study Arms (1)
Targeted Drug Therapy Group
EXPERIMENTALAll 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.
Interventions
Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
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 is a regimen used for refractory tumor without druggable target
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baodong Qinlead
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Related Publications (2)
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.
PMID: 37155342DERIVEDJiao 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.
PMID: 36910668DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan-Sheng Zang, MD.PHD
Shanghai Changzheng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 28, 2017
First Posted
August 3, 2017
Study Start
January 1, 2017
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
March 4, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share