Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Sponsor
Fudan University
Study ID
NCT05111444
Phase
PHASE2
Status
Unknown

Conditions

  • Gastric Neoplasms
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200 mg on Day 1 of each 3-week cycle as an IV infusion
  • Pyrotinib — DRUG
    320mg as continuous oral once daily on every 21 days
  • Capecitabine — DRUG
    1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of XELOX chemotherapy regimen
  • Oxaliplatin — DRUG
    130 mg/m\^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of XELOX chemotherapy regimen and as part of SOX chemotherapy regimen
  • Paclitaxel — DRUG
    80 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen
  • S-1 — DRUG
    Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): \<1.25 m\^2 BSA =40 mg, 1.25 to \<1.5 m\^2 BSA=50 mg, ≥1.5 m\^2 BSA=60 mg. Administered as part of SOX and TS chemotherapy regimen

Study Details

This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.

Key Dates

Start date
Dec 31, 2021
Status verified
Oct 2021
Primary completion
Dec 31, 2023
Completion
Jun 30, 2024

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Camrelizumab+Pyrotinib + Chemotherapy
    Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: [ Time Frame: Up to approximately 2 years ] ]

Central Contacts

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