Advanced Refractory Solid Tumors With TP53 Mutations Register Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-01-31

Brief Summary

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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 .

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Detailed Description

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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.

Conditions

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Solid Tumor, Adult

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Advanced refractory tumor solid tumors patients

Patients with advanced refractory solid tumors carrying TP53 mutations and receive PARP-inhibitors in combination with the VEGFR-inhibitors therapy

Data Collection

Intervention Type OTHER

Colleciton of data from medical records only

Interventions

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Data Collection

Colleciton of data from medical records only

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No