Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer: a Single-arm, Open Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To observe and evaluate the neoadjuvant treatment of Envafolimab combined with Fruquintinib and chemotherapy for locally advanced gastric/gastroesophageal junction carcinoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Have fully understood the study and voluntarily signed the informed consent;

• Aged 18-75 years (including 18 and 75 years);

• Pathologically confirmed or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT2-T4b, N+M0);

• If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, abdominal examination should be performed to rule out distant metastasis.

• At least 1 measurable lesion according to RECIST v1.1 criteria;

• United States Eastern Cancer Consortium (ECOG) Physical status score 0-1; BMI≥18;

• Expected survival ≥12 weeks;

• The functions of vital organs during the first 14 days of enrollment met the following requirements:

‣ Absolute neutrophil count ≥1.5×109/L;

⁃ Platelet ≥80×109/L;

⁃ Hemoglobin ≥90g/L;

⁃ Total bilirubin \< 1.5 ULN; ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis);

⁃ Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;

⁃ endogenous creatinine clearance \> 50ml/min;

• Female subjects of childbearing age or male subjects whose sexual partner is a female of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment period;

⁃ Good compliance, cooperate with follow-up.

Locations
Other Locations
China
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
Jianxin Ye Ye
yejianxinfuyi@126.com
13809553280
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-05
Participants
Target number of participants: 40
Treatments
Experimental: Envafolimab combined with Fruquintinib and chemotherapy
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Fujian Medical University

This content was sourced from clinicaltrials.gov