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Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

ConditionGastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital

About this trial

This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years old, no gender limitation;

Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；

Expected survival of ≥ 3 months;

The tumor specimens were PD-L1 positive (CPS ≥ 1)；

Disqualifiers

Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;

Patients with positive HER-2；

Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;

Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Taurine

    Dietary supplement

    Taurine supplementation in tablets of 1.0 gram of taurine powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

  • Serplulimab

    Biological/Vaccine

    Serplulimab

  • XELOX regimen

    Drug

    Oxaliplatin + capecitabine

  • Placebo

    Dietary supplement

    Taurine placebo in tablets of 1.0 gram of starch powder. Dosage: 3.0 gram/day. Frequency: 3 time/day.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Taurine + Serplulimab + XELOXExperimental treatment 3 interventions
Group B: Placebo + Serplulimab + XELOXActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response

To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.

Time frame
Through study completion, Within 1 week after operation

Secondary outcomes

1

R0 resection rate

The surgical margin is microscopically-negative for residual tumor.

Time frame
Through study completion, Within 1 week after operation
2

Major pathological response (MPR)

Residual tumor cells below 10% in the resected specimen.

Time frame
Through study completion, Within 1 week after operation
3

Objective response rate (ORR)

ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Time frame
Through study completion, an average of 1 year.
4

Disease-free survival (DFS)

DFS was defined as the time from surgery to postoperative recurrence or death from any cause, whichever occurred first. DFS was censored on the last tumor assessment date for patients still alive and without recurrence.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov
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