Clinical trial NCT06739395: Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion
Official title: A Pan-Cancer Basket, Real World, Open-label, Multicenter Study on Molecular Matching Therapy Guided by Molecular Tumor Boards (MTB) for Pan Solid Tumor Patients With Standard Treatment Exhaustion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumor
Precision Medicine
Lead sponsor: Tianjin Medical University Second Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.

Detailed description: Using comprehensive genome sequencing to analyze recurrent and metastatic solid tumors that have failed previous conventional treatments, and matching possible targeted therapy drugs to screen for potential effective treatment drugs until tumor disease progression, and then continuing to monitor tumor resistance mutation signals and provide matching therapy, can help improve the clinical outcomes of patients with advanced refractory tumors, and is also an important direction for personalized and precise treatment of tumors in the future. Therefore, the investigators designed this study to explore the feasibility, effectiveness, and safety of targeted therapy based on tumor molecular feature matching for advanced solid tumor patients who have failed previous treatments. 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. The core concepts of the clinical research interventional initiated include: target priority principle, combination therapy principle, individualized dose adjustment method for combination therapy, and Bayesian adaptive trial design. For some clinical studies, to meet the primary objective, at least 35% of participants had to achieve a PFS2(Progression-Free Survival 2)/PFS1(Progression-Free Survival 1) ≥ 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 PFS2/PFS1≥ 1.3 in ≤10% of patients would be clinically irrelevant, while a success rate ≥ 35% would merit further investigation.

Eligibility criteria: Inclusion Criteria:

1. Recurrent or metastatic malignant solid tumors diagnosed by histology or cytology;
2. ECOG score 0-4 (3-4 points only for patients with tumor burden);
3. Those who fail or cannot tolerate standard treatment, or those who refuse standard treatment;
4. At least one measurable lesion that meets the RECIST 1.1 standard;
5. Expected survival period ≥ 3 months;
6. Age ≥ 18 years old;
7. Tumor tissue blocks with sufficient formalin fixed paraffin embedding (FFPE), or chest or ascites with cancer cells detected during treatment (not less than 200ml), or excised metastatic lymph nodes, or peripheral blood (approximately 5m1) can be used for genetic testing;
8. Understand and voluntarily participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Patients who have actively undergone or are currently participating in clinical trials for treatment;
2. Serious or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental diseases/social conditions that limit the compliance with the research requirements) that the researchers think will confuse the research treatment response analysis;
3. Pregnant or lactating patients, or any patients with fertility, have not taken appropriate pregnancy prevention measures.

Primary outcomes:
measure: PFS2/PFS1(Progression Free Survival 2/Progression Free Survival 1)
timeFrame: 24 months
Secondary outcomes:
measure: OS(Overall Survival)
timeFrame: 24 months
measure: ORR(Objective Response Rate)
timeFrame: 24 months
measure: Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
timeFrame: 24 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical Unversity Second Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Second Hospital
name: Haitao Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: