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Status unknownNCT04695223Updated Jan 6, 2021

Arsenic Trioxide for Structural p53 Mutations

A Phase 2 interventional study of Arsenic Trioxide in Arsenic Trioxide, p53 Mutations and Refractory Cancer, sponsored by Shanghai Changzheng Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-06.

Sponsored by Shanghai Changzheng Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 p53 mutations with thermostability and transcriptional activity. Under Vivo and Vitro experiments, arsenic trioxide could reactivate mutated p53 to inhibit tumor. This trial aimed to explore the efficacy and safety of arsenic trioxide in refractory cancer patients with structural p53 mutations.

02

Conditions studied

  • Arsenic Trioxide
  • p53 Mutations
  • Refractory Cancer
  • Intractable Cancer
03

In context

Lead sponsor

Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Arsenic Trioxide

    Arsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection

    Drug: Arsenic Trioxide

Interventions

  • DrugArsenic Trioxide

    Refractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration)

    Also known as: As2O3, Arsenic

06

What researchers measure

Primary outcomes

  1. Objective Response Rate

    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

    Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months

  2. Progress Free Survival

    Time from treatment beginning until disease progression

    Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Secondary outcomes

  1. Overall Survival

    Time from treatment beginning until death from any cause

    Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months

  2. Adverse Effect

    Incidence of Treatment-related adverse Events

    Time frame: Through study completion, an average of 1 months

07

Study locations

1 of 1 sites recruiting
  • Department of Medical Oncology, Shanghai Changzheng Hospital
    Shanghai, China
    • Xiaodong Jiao · Contact · 13817797639@139.com · +86-13817797639
    • Yuan-Sheng Zang · Principal investigator
    Recruiting
08

References and documents

Publications

  • Tang Y, Song H, Wang Z, Xiao S, Xiang X, Zhan H, Wu L, Wu J, Xing Y, Tan Y, Liang Y, Yan N, Li Y, Li J, Wu J, Zheng D, Jia Y, Chen Z, Li Y, Zhang Q, Zhang J, Zeng H, Tao W, Liu F, Wu Y, Lu M. Repurposing antiparasitic antimonials to noncovalently rescue temperature-sensitive p53 mutations. Cell Rep. 2022 Apr 12;39(2):110622. doi: 10.1016/j.celrep.2022.110622. PubMed 35417717 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04695223
Lead sponsor
Shanghai Changzheng Hospital
Responsible party
Yuan-Sheng Zang (Department Director, Shanghai Changzheng Hospital) — Principal investigator
First posted
Jan 5, 2021
Start date
Jan 1, 2021 (estimated)
Primary completion
Aug 31, 2021 (estimated)
Completion
Oct 31, 2021 (estimated)
Last update
Jan 6, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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