Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients are able to understand and voluntarily sign the written informed consent, which must be signed prior to the implementation of the designated research procedures required by the study.

The age at the time of signing the informed consent form (ICF) is ≥ 18 years old, both male and female.

Histologically confirmed to have HER2-negative gastric or gastroesophageal junction adenocarcinoma (Siewert type II or Siewert type III with ≤2 cm of esophageal involvement) with AJCC 8th edition staging of Stage IIA- Stage III, i.e., T1- 2N+, and T3-4 and or N+, and resectable;.

The patients are willing to provide fresh blood, feces, and tumor tissue for biomarker analysis, and the tissue samples provided are of sufficient quality to evaluate the status of biomarkers. If sufficient tissue is not provided, repeated sampling may be required.

Disqualifiers

Palliative local treatment was given to non-target lesions within 2 weeks before the first administration, and systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) was received within 2 weeks before the first administration. Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications was received within 2 weeks before the first administration.

The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy, etc. any treatment aimed at the immune mechanism of tumor.

There was a history of gastrointestinal perforation and gastrointestinal fistula within 6 months before the first administration. If the perforation or fistula has been removed or repaired, and the disease has been judged by the researchers to recover or remission, it may be allowed to join the group.

Active or previously recorded inflammatory bowel disease (such as Crohn's disease or ulcerative colitis). Unable to swallow, malabsorption syndrome, or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal diseases that seriously affect drug use and absorption.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab

    Drug

    q3w Iparomlimab and Tuvonralimab 5mg/kg on day 1 of each cycle

  • Oxaliplatin

    Drug

    130mg/m2 on day 1 of each cycle

  • Tegafur

    Drug

    \<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid

  • Radiotherapy

    Radiation

    30 Gy/10 fractions

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 4 interventions
Group B: Group BExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR)

Time frame
8 months

Secondary outcomes

1

Major Pathologic Response (MPR)

Time frame
8 months
2

Objective Response Rate (ORR)

Time frame
7 months
3

Disease Control Rate (DCR)

Time frame
7 months
4

Progression Free Survival (PFS)

Time frame
3 years

Other outcomes

1

Adverse events (AE)

Time frame
6 months
2

Correlation analysis of evaluating the relationship between clinicopathological characteristics and neoadjuvant immunochemotherapy and radiotherapy

Time frame
3 years
3

Correlation analysis of evaluating the relationship between multi-omics analysis of tumor tissue and neoadjuvant immunochemotherapy efficacy

Time frame
3 years

Sponsors and contacts

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