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Prospective Clinical Study of Individualized Precision Treatment of Refractory Solid Tumors under Guidance of Molecular Tumor Board in Real World

Prospective Clinical Study of Individualized Precision Treatment of Refractory Solid Tumors under Guidance of Molecular Tumor Board in Real World

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027104
Enrollment
Unknown
Registered
2019-10-31
Start date
2019-11-10
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Solid Tumor

Interventions

Molecular Tumor Board Guided Treatment Group:Targeted drug therapy

Sponsors

Bo'ao Super Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Patients can provide detailed clinical baseline information including: name, age, gender, pathology, past treatment, etc.; 3. ECOG 0-4; 4. The estimated total survival period is not less than 12 weeks; 5. Patients with solid tumors diagnosed by pathology, including patients with solid tumors of unknown origin; 6. Refractory solid tumors are mainly defined as solid tumor patients without standard treatment before enrollment or no treatment after multi-line treatment failure; 7. The patient is able to receive treatment advice from the Molecular Oncology Committee; 8. Specific molecular characteristics The treatment group was previously unable to receive treatment with related inhibitors including the following: Group A: After the NGS sequencing, the MTB expert committee determined that there were harmful mutations in the PI3K/AKT/mTOR pathway genes (such as AKT, mTOR, TSC1, TSC2, etc.) and that the main clone features were not previously treated with this pathway inhibitor; Group B: After the NGS sequencing, the MTB expert committee judged that there were harmful mutations in Homologous Recombination (HR) genes (such as BRCA1/2, PALB2, ATM, ATR, RAD51, etc.) and the main clones had not been accepted before. PARP inhibitor treatment; Group C: After the NGS sequencing, the MTB expert committee judged that there was a missense mutation of the TP53 gene and the main clone had not been treated with PARP inhibitor and VEGFR inhibitor before; Group D: After the NGS sequencing, the MTB expert committee judged that there was harmful variation of BRAF/MEK gene and the main clone did not receive excessive target kinase inhibitor treatment and BRAF/MEK and other related inhibitors. Group E: After the NGS sequencing of the patient, the MTB expert committee determined that there was a harmful mutation in the CDK12 gene and the main clone was either TMB-H or Mismatch Repair Deficient (MRD). The expression of PD-L1 was not previously accepted. Immunosuppressive drug therapy; Group F: Other molecular features identified by the MTB expert group and previously not treated with recommended drugs; 9. Can provide NGS data approved by the Molecular Oncology Committee; 10. Imaging examination has at least one measurable lesion with a diameter >=10 mm; 11. Be able to follow the research and follow-up procedures to provide real and effective information; 12. The follow-up period must be at least greater than 2 months; 13. The patient or his legal guardian understands the test procedure and content and voluntarily signs the Informed Consent Forms (ICF).

Exclusion criteria

Exclusion criteria: 1. Patients with no self-awareness and mental disorders; 2. Other serious diseases or conditions; 1) Severe, uncontrolled medical conditions and infections; 2) Severe uncontrollable digestive disorders; 3) Severe electrolyte imbalance; 4) Active disseminated intravascular coagulation; 5) Major organ failure, such as decompensated heart, lung, liver, kidney failure; 6) Other investigators believe that they cannot be enrolled because of serious illness; 3. Can not tolerate the corresponding molecular targeted therapy and reject all other treatments; 4. At the same time using other test drugs or in other clinical trials; 5. Patients who are considered inappropriate by the investigator (inferior compliance, inability to follow up, etc.).

Design outcomes

Primary

MeasureTime frame
Objective Response Rate, ORR;

Secondary

MeasureTime frame
Progress Free Survival, PFS;Duration of Response, DOR;Disease Control Rate, DCR;Overall Survival, OS;Safety related indicators;

Countries

China

Contacts

Public ContactHaitao Wang

Tianjin Medical University

peterrock2000@126.com+86 18630955984

Outcome results

None listed

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