Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Tianjin Medical University Second Hospital100 enrolled

Overview

The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .

TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Solid Tumor, Adult

Interventions

Data CollectionOTHER

Colleciton of data from medical records only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Is equal to or greater than 18 years of age. 2. Histologic or cytologic confirmation of advanced refractory solid tumors with no standard treatment options, including some patients with advanced disease in reduced general condition (Eastern Cooperative Oncology Group (ECOG) 3 and 4). 3. Patients with measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. 4. Patients must be able to provide blood samples or tissue samples for NGS (Next Generation Sequencing) testing for understanding the TP53 gene status. The amount of blood and tissue samples should be able to meet the requirements of DNA extraction and quality control. 5. Adequate baseline organ system function. 6. Patients could receive treatment program from MTB (Molecular Tumor Board). 7. No prior treatment with PARP combined with VEGFR inhibitions. 8. Ability to understand and the willingness to provide a written informed consent document. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected. 3. Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication. 4. Active infection requiring systemic therapy. 5. Patients unable to swallow orally administered medication. 6. Prior treatment with PARP or VEGFR inhibitions. 7. According to the investigator'judgment, there are serious, uncontrollable risks to patients'safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.

Locations (1)

Tianjin Medical Unversity Second Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

ORR(Objective Response Rate)

ORR is the percentage of participants with best overall response of complete response (CR), partial response (PR). Response categories: CR, PR, SD (stable disease), PD (progressive disease) Criteria on which physicians determined therapy response also will be captured by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate.

Time frame: Up to three months

Secondary Outcomes

PFS (Progression Free Survival), calculated from various time points

Progression-free survival (PFS) is defined as progression free survival of all the evaluable participants who receive targeted drug therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).

Time frame: Up to two years

OS (Overall Survival), calculated from various time points

OS is defined as time from initiation to death of any cause.

Time frame: Duration of time from the start of treatment to date of death, assessed up to two years

ADR (Adverse Drug Reaction)

Adverse events determined according to CTCAE (version 4.03).

Time frame: 30 days after last dose

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.