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Treatment of Advance Gastric Cancer With Disulfiram

NCT ID: NCT05667415

Last Updated: 2022-12-28

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.Subjects were randomized in a 1:1 ratio, one group being the control group and the other group being the observation group. Control group: On the first day of treatment, the patients were given intravenous drip of 80mg/m2 cisplatin, 21 days as a course of treatment, lasting for six courses. Observation group: On the first day of treatment, the patients were given intravenous drip of 80mg/m2 cisplatin, 21 days as a course of treatment, lasting for six courses. Disulfiram 400mg was given orally daily and continued until the end of the chemotherapy course. Based on the patient's tolerance to disulfiram, the disulfiram dose may be reassessed during treatment with a minimum oral dose of 125mg per day. The clinical symptoms, signs and adverse reactions were observed in the patients, and the treatment effect was evaluated after three weeks as a cycle and two cycles.

Conditions

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Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Combination regimen of disulfiram and cisplatin for gastric cancer and standard cisplatin regimen for gastric cancer
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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disulfiram and cisplatin

Cisplatin combined with disulfiram chemotherapy

Group Type EXPERIMENTAL

disulfiram and cisplatin

Intervention Type 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.

standard cisplatin

Cisplatin chemotherapy alone

Group Type ACTIVE_COMPARATOR

cisplatin

Intervention Type 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.

Interventions

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disulfiram and cisplatin

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.

Intervention Type DRUG

cisplatin

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.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

3. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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College of Pharmaceutical Sciences at Zhejiang University

UNKNOWN

Sponsor Role collaborator

The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

UNKNOWN

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Zhang Xiaofeng,MD

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hangzhou first people's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Hongzhang Shen

Role: CONTACT

Phone: 057156005600

Email: [email protected]

Xiaofeng Zhang

Role: CONTACT

Phone: 057156005600

Other Identifiers

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20221212

Identifier Type: -

Identifier Source: org_study_id