Solid Tumor
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival, PFS;Duration of Response, DOR;Disease Control Rate, DCR;Overall Survival, OS;Safety related indicators; | — |
Countries
China
Contacts
Tianjin Medical University