Treatment of Advance Gastric Cancer With Disulfiram

NCT05667415 | Not Yet Recruiting

• 1 other identifier: 20221212
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy is generally needed for advanced gastric cancer, and cisplatin is the main chemotherapy drug. However, there are many adverse reactions, including bone marrow suppression, gastrointestinal reactions, renal toxicity and neurotoxicity. These adverse reactions can affect the comfort and compliance of patients during treatment. At present, it is necessary to reduce adverse reactions of cisplatin and increase the chemotherapy sensitivity of gastric cancer to cisplatin. Recent studies have found that disulfiram has a potential anti-tumor effect. The disulfiram has shown significant in vivo and in vitro anti-tumor activity in preclinical studies, and has become a potential candidate drug for tumor treatment as an adjuvant in various clinical trials. In this clinical study, cisplatin combined with disulfiram is mainly used to treat advanced gastric cancer.

Conditions

Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram

Outcome Measures

Primary Outcomes (4)

• Complete response (CR)

  The tumor lesion in our patient completely resolved and lasted for ≥4 weeks, and no new lesion appeared

  every 6 weeks

• Partial response (PR)

  the overall reduction in the longest diameter of the tumor focus is \> 50% and it can be maintained for at least 4 weeks, with no new focus emerging

  every 6 weeks

• Stable disease (SD)

  the overall reduction or increase of the longest diameter of the tumor lesion is \< 50% or \< 25%, and the duration is \> 4 weeks; no new lesion appears

  every 6 weeks

• Disease progression (PD)

  the combined increase in the longest diameter of the tumor lesion is ≥25%, or a new lesion appears

  every 6 weeks

Study Arms (2)

disulfiram and cisplatin

EXPERIMENTAL

Cisplatin combined with disulfiram chemotherapy

Drug: disulfiram and cisplatin

standard cisplatin

ACTIVE COMPARATOR

Cisplatin chemotherapy alone

Drug: cisplatin

Interventions

disulfiram and cisplatin DRUG

on the first day of treatment, patients were given intravenous drip of 80mg/m2 cisplatin, and 21 days was a course of treatment, lasting for 6 courses. Take 400mg disulfiram orally every day, and continue to use it until the end of chemotherapy. According to the patient's tolerance to disulfiram, the dose of disulfiram can be re-evaluated during the treatment, and the lowest dose is 125mg per day. The clinical symptoms, signs and adverse reactions of patients were observed, and the treatment effect of patients was evaluated after two consecutive cycles with 3 weeks as a cycle.

disulfiram and cisplatin

cisplatin DRUG

on the first day of treatment, patients were given 80mg/m2 cisplatin intravenously, and 21 days was a course of treatment, lasting for 6 courses.

standard cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Shedding/eliminating criteria: exiting in the midway; Lost to follow-up during the follow-up period; Treatment was not continued according to the treatment protocol.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• College of Pharmaceutical Sciences at Zhejiang University: collaborator
• The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University: collaborator

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Disulfiram; Cisplatin

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Hongzhang Shen

CONTACT

057156005600; sakshen@126.com

Xiaofeng Zhang

CONTACT

057156005600

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: Combination regimen of disulfiram and cisplatin for gastric cancer and standard cisplatin regimen for gastric cancer

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 28, 2022
• Study Start: June 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)