Clinical trial · Interventional
Efficacy and Safety of Precision Therapy in Refractory Tumor
Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
NCT03239015CI-TRIAL-00056907unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rare Tumor | Rare Neoplasm | ALIAS | 0.90 |
| Refractory Tumor | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Everolimus | Drug | Everolimus | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Olaparib | Drug | Olaparib | ALIAS |
| Oxazolidine | Drug | — | UNRESOLVED |
| Palbociclib | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targeted Drug Therapy 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.
- interventionNames
- Drug: Gefitinib
- Drug: Erlotinib
- Drug: Afatinib
- Drug: Trastuzumab
- Drug: Oxazolidine
- Drug: Olaparib
- Drug: Everolimus
- Drug: Cabozantinib
- Drug: Vemurafenib
- Drug: Dabrafenib
- Drug: Palbociclib
- Drug: PD-1/L1 inhibitor plus anti-angiogenic agent
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (2)
- DERIVEDQin 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 37155342
- DERIVEDJiao 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 36910668