Comparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Have a good understanding of the study, are willing to follow the requirements of the study, and voluntarily sign the informed consent form.

• Aged ≥ 18 years old and ≤ 75 years old.

• Locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma confirmed by pathological histology or cytology.

• No previous systemic therapy. Note: Patients who have previously received neoadjuvant or adjuvant therapy may be enrolled if they have ended treatment without recurrence or disease progression for at least 6 months.

• Agree to provide a previously stored tumor tissue sample or a biopsy to collect tumor tissue.

• ECOG PS score is in the range of 0\

• Expected survival time ≥ 3 months.

• Subjects having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other corrective therapy drugs are allowed to be given within the first 14 days of obtaining laboratory tests), as follows:

‣ Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; platelet count (PLT) ≥ 75×10\^9/L; hemoglobin level (HGB) ≥ 7.5 g/dL.

⁃ Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g/L.

⁃ Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance\>50 mL/min.

• Female subjects of childbearing age or male subjects whose sexual partners are at childbearing age are required to take effective contraception measures throughout the treatment period and for 6 months after the treatment

Locations
Other Locations
China
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Affliated Cancer Hospital of Guizhou Medical University
RECRUITING
Guiyang
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The Second Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Ruihua Xu, MD
xurh@sysucc.org.cn
+86 20 87343795
Backup
Feng Wang, MD, PhD
wangfeng@sysucc.org.cn
+86 20 87343795
Time Frame
Start Date: 2023-04-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 540
Treatments
Experimental: Modified XELOX + sintilimab
The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years.
Active_comparator: Standard XELOX + sintilimab
The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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