Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04631757
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab + SOX + Radiotherapy — DRUG
    Camrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d

Study Details

This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.

Key Dates

Start date
Dec 15, 2020
Status verified
Nov 2020
Primary completion
Jun 30, 2022
Completion
Dec 31, 2023

Study Design

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

Arms

  • Experimental: Camrelizumab plus Chemoradiotherapy
    Patients with initial unresectable proximal gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive camrelizumab 200mg q3w, SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14, Q3w), and intensity modulated radiotherapy for tumors and high-risk lymphatic drainage areas (45Gy/25d). Resectable patients after conversion therapy will receive D2 resection.

Primary Outcome Measure

1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment [ Time Frame: Up to approximately 12 months ]

Central Contacts

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