Treatment of Advance Gastric Cancer With Disulfiram

Study Overview
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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.

Official Title
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Clinical Study of Disulfiram Combined With Cisplatin in the Treatment of Advanced Gastric Cancer

Conditions
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Chemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram

Intervention / Treatment
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* Drug: disulfiram and cisplatin
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ① Age ≥18 years old; ② Gastric cancer is confirmed through gastroscopy biopsy; ③ The patient meets the relevant diagnostic criteria in People's Republic of China (PRC) Health Industry Standards: Diagnostic Criteria for Gastric Cancer, and has reached the level of stage III and IV futures, and the patient refuses to receive surgical treatment; ④ Estimated survival time > 3 months; ⑤ Without any chemotherapy treatment or more than one month from the end of the last chemotherapy course; ⑥Karnofsky functional status score ≥ 60; Exclusion criteria: ① patients who had allergic reaction to therapeutic drugs; ② patients with other types of cancer; ③ Patients with severe diseases of heart, liver, kidney, etc.; (4) gastrointestinal dysfunction or unable to oral medication. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Combination regimen of disulfiram and cisplatin for gastric cancer and standard cisplatin regimen for gastric cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: disulfiram and cisplatin<br>Cisplatin combined with disulfiram chemotherapy | Drug: disulfiram and cisplatin<br>* 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.<br>|
| Active Comparator: standard cisplatin<br>Cisplatin chemotherapy alone | Drug: cisplatin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |