Arsenic Trioxide in Refractory Solid Tumors With Rescuable p53 Mutation

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open, prospective, single arm, multi center exploratory basket clinical study. 20 refractory solid tumors patients with rescuable p53 mutation will be enrolled, and the efficacy and safety of arsenic trioxide in those patients will be evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Arsenic Trioxide

Criteria

Inclusion Criteria:

1. Male/female patients aged≥18 years.

2. Patients with refractory solid tumors were confirmed by histopathology and structural p53 mutations were confirmed by sanger sequence.

3. ECOG performance status 0 or 2, expected lifetime≥3 months.

4. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.

5. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).

6. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.

7. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.

2. brain or meningeal metastasis.

3. With second primary malignant diseases.

4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).

5. With uncontrollable complications

6. Inadequate organ function

7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).

8. known hypersensitivity reaction to any of the study drugs or components.

9. Other unsuitable conditions determined by investigators.