Molecular phenotype study of advanced refractory solid tumors and exploratory clinical trials of PDX model construction

Prospective Clinical Study of Integrating Next Generation Sequencing (NGS) Interpretation with Real-time PDX Preclinical Model for N of one Drug Combination Therapy in Nonactionable or Low Evidence Actionable Gene Alterations: Single-Center, Pilot Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048697

Enrollment

Unknown

Registered

2021-07-12

Start date

2017-06-01

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory solid tumor

Interventions

Cohort A:TP53 clonal alteration:ARP inhibitor based combination therapy

Cohort B:KRAS clonal alteration:Trametinib based combination therapy

Cohort C: PTEN clonal alteration:Everolimus based combination therapy

??D:Other complex co-mutations:Combination therapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Recurrent or metastatic malignant solid tumor confirmed by histology; 2. ECOG PS score 0-4 (3-4 points only for patients with tumor load); 3. Standard treatment exhaustion; 4. At least one measurable lesion in accordance with recist1.1; 5. The target lesion is not suitable for local treatment; 6. The expected survival time is more than 3 months; 7. Aged >= 18 years; 8. The main organs function well; 9. Patients must have enough tissue samples for gene mutation detection; 10. Patients in the treatment group should agree to accept puncture for the construction of in vitro drug screening model; 11. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The main lesions are suitable for local treatment; 2. Severe or uncontrolled medical diseases (i.e. uncontrolled diabetes, chronic kidney disease, chronic lung disease or uncontrolled active infection, mental illness / social status limiting the compliance of research requirements) that researchers believe will be confused in the treatment response analysis of the study; 3. Pregnant or lactating patients or any fertile patients did not take appropriate pregnancy prevention measures.

Design outcomes

Primary

Measure	Time frame
Percentage of receiving MiniPDX-guided targeted combination therapy;	—

Secondary

Measure	Time frame
Objective Response Rate(ORR);Progression-free survival(PFS);Overall Survival(OS);Progress Free Survival 2/ Progress Free Survival (PFS2/PFS1);	—

Countries

China

Contacts

Public ContactHaitao Wang

The Second Hospital of Tianjin Medical University

peterrock2000@126.com+86 18630955984

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026