Rare TumorPhase 2NCT03239015
Efficacy and Safety of Precision Therapy in Refractory Tumor
A Phase 2 study testing Gefitinib, Erlotinib and Afatinib in people with Rare Tumor and Refractory Tumor, run by Baodong Qin at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rare Tumor, Refractory Tumor
- What is being tested?
- Gefitinib, Erlotinib and Afatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Xiao-Dong Jiao, MD, +86-13817797639, pulava@139.com
About this study
Official title: Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
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.
Read the 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
- Being tested
- Gefitinib, Erlotinib, Afatinib, Trastuzumab, Oxazolidine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
ErlotinibDrug
Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
AfatinibDrug
Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
TrastuzumabDrug
Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
OxazolidineDrug
Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
OlaparibDrug
Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
EverolimusDrug
Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
CabozantinibDrug
Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
VemurafenibDrug
Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
DabrafenibDrug
Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
PalbociclibDrug
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 agentDrug
PD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Secondary outcomes (3)
Progress Free Survival
Time from treatment beginning until disease progression
Measured: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Overall Survival
Time from treatment beginning until death from any cause
Measured: 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
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rare TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baodong Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baodong Qin, Shanghai Changzheng Hospital
- Investigators
- Yuan-Sheng Zang, MD.PHD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239015
- Sponsor's protocol ID
- Long March Pathway
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2017
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37155342Jiao 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.
PubMed 36910668
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
- ClinicalTrials.gov ID
- NCT03239015
- Acronym / sponsor ID
- Long March Pathway
- Conditions
- Rare Tumor, Refractory Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baodong QinUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Drug Therapy Group | Experimental | 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 agentAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibGefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| ErlotinibErlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| AfatinibAfatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| TrastuzumabTrastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results. | Drug | Targeted Drug Therapy Group |
| OxazolidineOxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results. | Drug | Targeted Drug Therapy Group |
| OlaparibOlaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| EverolimusEverolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| CabozantinibCabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| VemurafenibVemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| DabrafenibDabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results. | Drug | Targeted Drug Therapy Group |
| PalbociclibPalbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results. | Drug | Targeted Drug Therapy Group |
| PD-1/L1 inhibitor plus anti-angiogenic agentPD-1/L1 inhibitor plus anti-angiogenic agent is a regimen used for refractory tumor without druggable target | Drug | Targeted Drug Therapy Group |
Primary outcome
Objective Response Rate
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
3 secondary outcomes
Progress Free Survival
Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Overall Survival
Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Time frame: Through study completion, an average of 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 37155342Qin 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.
- Derived from this study: PubMed 36910668Jiao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Sheng Zang, MD.PHD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib, Erlotinib and Afatinib in people with Rare Tumor and Refractory Tumor, run by Baodong Qin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-dong Jiao, MD.PHD (+86-13817797639, pulava@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.