Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Drug Therapy Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-dong Jiao, MD.PHD | Contact | +86-13817797639 | pulava@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan-Sheng Zang, MD.PHD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37155342 | Derived | 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. | |
| 36910668 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000069347 | Erlotinib Hydrochloride |
| D000077716 | Afatinib |
| D000068878 | Trastuzumab |
| C064210 | oxazolidine |
| C531550 | olaparib |
| D000068338 | Everolimus |
| C558660 | cabozantinib |
| D000077484 | Vemurafenib |
| C561627 | dabrafenib |
| C500026 | palbociclib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Erlotinib | Drug | Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. |
|
| Afatinib | Drug | Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. |
|
| Trastuzumab | Drug | Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results. |
|
| Oxazolidine | Drug | Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results. |
|
| Olaparib | Drug | Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results. |
|
| Everolimus | Drug | Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results. |
|
| Cabozantinib | Drug | Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results. |
|
| Vemurafenib | Drug | Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. |
|
| Dabrafenib | Drug | Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. |
|
| Palbociclib | 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 | Drug | PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target |
|
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 |
| Adverse Effect | Incidence of Treatment-related adverse Events | Through study completion, an average of 1 months |
| 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. |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |