Next Generation Sequencing, Refractory Solid Tumors
Conditions
Keywords
Precision medicine, NGS, Molecular Tumor Board(MTB)
Brief summary
The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven basket (tissue-type agonistic) study. The target population covers a variety of solid advanced malignant tumors, including but not limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck squamous carcinoma or lacking effective treatment after standard treatment failure.
Detailed description
The MyCustom study is a investigator initiated trial(IIT), prospective real-world clinical research project, a genetic biomarker-driven basket (tissue-type agonistic) study. The target population covers a variety of solid advanced malignant tumors, including but not limited to patients with small cell lung, gastric, prostate, bladder cancer, head and neck squamous carcinoma or lacking effective treatment after standard treatment failure.The overall goal is to develop a more effective research method to test new individualized treatment hypotheses.This study will provide comprehensive theoretical and practical support for individualized custom model in refractory solid tumors.Archival pathology laboratory samples from patients with treatment-refractory advanced solid cancer of any histologic type undergo Next Gene Sequencing(NGS) analysis.Fllowing obtain the raw data of the patient's gene sequencing, the data are analyzed by the auxiliary decision algorithm to obtain the prioritization results of the drugs matched by this patient.The results are subsequently reviewed by the Molecular Tumor Board (MTB), where eligible patients can be treated in treatment substudies.All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including clinical efficacy ,clinical safety and exploratory endpoints such as biomarkers for drug response, change in the tumor microenvironment. For some clinical studies, to meet the primary objective, at least 35% of participants had to achieve a PF2S/PFS1 ≥ 1.3 in a sample population of 25 evaluable patients. sample size was calculated using an exact single-stage design for phase II studies with a one-sided type I error of 5% and a power of 90% under the assumption that PF2S/PFS1≥ 1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would merit further investigation.
Interventions
None listed
Sponsors
Tianjin Medical University Second Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid cancer of any histological type, or an earlier diagnosis of cancer with a poor prognosis. Suffificient accessible tissue for molecular profifiling; 2. Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment; 3. ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4)); 4. Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments; 5. Signed, written informed consent to participate.
Exclusion criteria
1. Suitable for standard therapy; 2. Specific contraindications to exposure to the investigationalproducts; 3. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol; 4. Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer; 5. Pregnancy, lactation or inadequate contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1) | 3 years | The time to progression-free survival during the substudy (PFS2) exceeds the documented time to disease progression-free survival during the last treatment prior to substudy entry (PFS1) by at least 35% (ie, PFS2/PFS1≥1.3) or, if PFS1 is not evaluable, time to progressive disease exceeds 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR(Objective Response Rate) | 3 years | Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria. |
| OS(Overall Survival) | 3 years | Evaluation of overall survival (OS) defined as the time between inclusion and death, whatever the cause is. Alive patients will be censored at their last known contact date. |
| Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0 | 3 years | Treatment related adverse events with grade 3 or greater severity by CTCAE 5.0. |
| Proportion of patients with actionable target | 3 years | Number of patients with modifiable genomic variants. |
Countries
China
Contacts
Primary ContactHaitao Wang, Ph.D
Backup ContactLili Wang, M. Med.
Outcome results
None listed