Status:
UNKNOWN
Arsenic Trioxide for Structural p53 Mutations
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Arsenic Trioxide
p53 Mutations
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
TP53 is the most frequently mutated gene in cancer, but these mutations remain therapeutically non-actionable. Previous study reported arsenic trioxide could rescue structural p53 mutations, endowing ...
Eligibility Criteria
Inclusion
- Malignant solid tumors diagnosed histologically;
- Solid tumor patients have no any standard choice after multiple line of therapy;
- Next-generation Sequence showed TP53 mutation;
- Expected survival ≥ 1 month;
- ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
- normal cardiac function
- obtain informed consent
Exclusion
- Patient still has standard treatment therapy based on NCCN guidance;
- Patient can not comply with research program requirements or follow-up;
- woman who are pregnant or breastfeeding;
- allergic to any drug in protocol or with contraindications;
- cannot understand or obey the protocol;
- with a history of allergies or intolerability;
- participate in other clinical trials meanwhile;
- any situations that hinder trial existed;
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04695223
Start Date
January 1 2021
End Date
October 31 2021
Last Update
January 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China