Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer

NCT06791083 | Recruiting Phase 2

• 1 other identifier: HMPL-013-E1-GC003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate (MPR)

  MPR is defined as the proportion of neoadjuvant therapy induced tumor regression with pathologically remaining tumor \< 10%

  up to 12 months

Secondary Outcomes (6)

• Pathological complete response rate (pCR)

  up to 12 months

• Pathological response rate (pRR)

  up to 12 months

• Objective response rate (ORR)

  up to 12 months

• Disease-free survival (DFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 years

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 10 years

Other Outcomes (1)

• Relationship between tumor angiogenesis and lymphangiogenesis and clinical outcomes

  Through study completion, an average of 1 year

Study Arms (1)

Envafolimab combined with Fruquintinib and chemotherapy

EXPERIMENTAL

Drug: Envafolimab; Drug: Fruquintinib

Interventions

Envafolimab DRUG

150mg/m2 , IH， d1；Q3W

Envafolimab combined with Fruquintinib and chemotherapy

Fruquintinib DRUG

5 mg ，po，QD，d1-d14；Q3W

Envafolimab combined with Fruquintinib and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \&lt; 1.5 ULN; ALT and AST \&lt; 2.5 ULN (\&lt; 5 ULN in patients with liver metastasis);
• Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
• endogenous creatinine clearance \&gt; 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;

You may not qualify if:

• Known HER2-positive patients;
• Participated in other drug clinical trials and received at least one drug therapy within 4 weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, immunotherapy, and other investigational drugs within 4 weeks prior to enrollment;
• Had other malignancies within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
• Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
• Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
• Previously received allogeneic bone marrow transplantation or organ transplantation;
• The patient has a current disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
• Subjects who are allergic to the investigational drug or any of its adjuncts;
• The investigator identified clinically significant electrolyte abnormalities;
• Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg;
• Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
• Patients with significant evidence or history of bleeding tendency within 3 months (bleeding \&gt;30 mL within 3 months, accompanied by hematemesis, stool, and blood in the stool), hemoptysis (\&gt;5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to admission;
• History of severe cardiovascular and cerebrovascular diseases:
• Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interval ≥ 450ms for men and 470 ms for women) within 6 months prior to first administration of the study drug (QTc interval Fridericia) Formula calculation);
• New York Heart Association (NYHA) heart function Grade \&gt; II or left ventricular ejection fraction (LVEF) \&lt; 50%;

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

envafolimab; HMPL-013

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Jianxin Ye Ye

CONTACT

13809553280; yejianxinfuyi@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: January 24, 2025
• Study Start: June 20, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)