Tislelizumab Combined with SOX Regimen in the Treatment of Locally Advanced Gastric Cancer/gastroesophageal Junction Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLiaoning Cancer Hospital & Institute

About this trial

This study is to evaluate the efficacy of neoadjuvant long-term treatment with tislelizumab in combination with SOX in the treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to participate in this study, able to sign the informed consent form, and with compliance;

No gender restriction, aged ≥18 and ≤70 years (at the time of signing the informed consent form);

ECO score of 0-1;

Estimated survival ≥6 months;

Disqualifiers

Have had or simultaneously have other active malignant tumors within 5 years. Cured localized tumors, as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast in situ, are eligible;

Patients who are preparing for or have previously undergone organ or bone marrow transplantation;

Have ≥2 grade myocardial ischem or myocardial infarction, arrhythmia (QTc ≥470ms), and ≥2 grade congestive heart failure (New York Heart AssociationNYHA] classification);

Human immunodeficiency virus (HIV) infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab + SOX

    Drug

    tislelizumab combined with SOX

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Tislelizumab + SOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathologic complete response rate (pCR)

Time frame
3 week

Secondary outcomes

1

The R0 resection rate after radical operation

Time frame
1 year
2

Major Pathological response (MPR) after radical operation

Time frame
From baseline to after radical operation
3

Event Free Survival Rate from baseline to 1 year

Time frame
from baseline to 1 year
4

Overall Survival rate from baseline to 1 year

Time frame
From baseline to 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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