A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patie… (NCT04661150) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction
China42 participantsStarted 2021-03-12
Plain-language summary
This is a phase II, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of perioperative trastuzumab+XELOX with / without atezolizumab in participants eligible for surgery with locally advanced HER2-positive gastric cancer or adenocarcinoma of GEJ.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed gastric cancer or adenocarcinoma of GEJ
* HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by in situ hybridization (ISH) as assessed by local review based on pretreatment endoscopic biopsies.
* Clinical stage at presentation: cT3/T4a/T4b, or N+, M0 as determined by AJCC staging system, 8th edition
* Availability of pretreatment tumor specimen for biomarker analysis by central lab
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy \>= 12 weeks
* Adequate hematologic and end-organ function
* For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception during the treatment period and to continue its use for at least i) 5 months after the last dose of atezolizumab, ii) 7 months after the last dose of trastuzumab, or iii) 6 months after the last dose of capecitabine or oxaliplatin, whichever is longer.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria:
* Stage IV (metastatic) or unresectable gastric/GEJ cancer determined by investigators
* Prior systemic therapy for treatment of gastric cancer
* History of malignancy other than GC within 5 years prior to screening, with the exception of malignancies with a negligible risk…
What they're measuring
1
Pathological Complete Regression (pCR) Rate
Timeframe: Completion of neoadjuvant systemic therapy (up to approximately 16 months)