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Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma

NCT07529613 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-14

No results posted yet for this study

Summary

To evaluate the safety and tolerability of the combination therapy of T-DXd, nivolumab, and chemotherapy in patients with untreated HER2-low gastric or gastroesophageal junction adenocarcinoma, and to determine the recommended dose. Subsequently, the efficacy and safety at the recommended dose will be assessed.

Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

T-DXd

T-DXd (4.4mg/kg, intravenous, q3w)

DRUG

Nivolumab

Nivolumab (360 mg, intravenous, q3w)

DRUG

Capecitabine

Capecitabine (750mg/m2 twice daily, days 1-14, orally)

DRUG

Oxaliplatin

Oxaliplatin (70mg/m2, intravenous, q3w)

Sponsors & Collaborators

  • National Cancer Center Hospital East

    lead OTHER

Principal Investigators

  • Kohei Shitara, MD · National Cancer Center Hospital East

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529613 on ClinicalTrials.gov