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Treatment of Advance Gastric Cancer With Disulfiram

ConditionChemotherapy；Advanced Gastric Cancer；Cisplatin；Disulfiram
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst People's Hospital of Hangzhou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: disulfiram and cisplatinExperimental treatment 1 intervention
Group B: standard cisplatinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete response (CR)

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

Time frame
every 6 weeks
2

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

Time frame
every 6 weeks
3

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

Time frame
every 6 weeks
4

Disease progression (PD)

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

Time frame
every 6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First People's Hospital of Hangzhou

Lead sponsor

College of Pharmaceutical Sciences at Zhejiang University

Collaborator

The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: