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Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer

ConditionsGastric / Gastroesophageal Junction AdenocarcinomaMSI-H Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University

About this trial

A randomized controlled phase II study exploring first-line treatment options for recurrent/metastatic MSI-H gastric cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g/dL.

Blood chemistry: creatinine clearance ≥50 mL/min, Creatinine (Cr) ≤ 1.5 × ULN, alanine aminotransferase (ALT) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, aspartate aminotransferase (AST) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）,

International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or < 1000mg/24h; 13. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .

Pregnant or lactating women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab

    Drug

    Iparomlimab and tuvonralimab for experimental arm

  • First line chemotherapy plus PD-1/PD-L1 antibody

    Drug

    standard first-line chemotherapy（FOLFOX/XELOX/SOX）combined with PD-1/PD-L1 antibody for control arm

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 1 intervention
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antitumor efficacy-Objective response rate (ORR)

The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).

Time frame
2 years

Secondary outcomes

1

Antitumor efficacy-Progression-free survival (PFS)

The period from the day of randomization to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.

Time frame
2 years
2

Antitumor efficacy-Overall survival (OS)

The period from the day of randomization to any cause of death

Time frame
2 yeas
3

Treatment related AEs

Time frame
2 years
4

Antitumor efficacy-Duration of response (DOR)

The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Peking University

Lead sponsor

Peking University Cancer Hospital & Institute

Collaborator

Qilu Pharmaceutical Group Co., Ltd

Collaborator

Source ClinicalTrials.gov
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