Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
Phase 2
Recruiting
- Conditions
- Metastatic or Recurrent Gastric Adenocarcinoma
- Interventions
- Registration Number
- NCT05237349
- Lead Sponsor
- Liangjun Zhu M.M.
- Brief Summary
The objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma.
- Detailed Description
Envafolimab indication: Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- 18-75 years；
- ECOG 0-1；
- life expectancy of at least 3 months；
- Negative for HER2 gene expression by central laboratory ；
- The tumor expresses PD-L1 as detected by the central laboratory, and the tumor proportion score (CPS) ≥ 1；
- At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
- Diagnosed by histology and/or cytology, and assessed by imaging (refer to RECIST 1.1) as advanced metastatic gastric adenocarcinoma or gastric adenocarcinoma that has recurred after previous gastric cancer surgery;
- Not received systemic chemotherapy in the past. Patients who have previously received fluorouracil monotherapy or fluorouracil-based adjuvant therapy or neoadjuvant therapy, and patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial. In cases of metastatic disease requiring local remission, remission therapy with radiosensitizing doses of fluorouracil or capecitabine alone is permitted only ；
- satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects ；
Exclusion Criteria
- Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- Pathologically suggested patients with abnormally increased AFP OR MSI-H ；
- Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
- Subjects with any severe and/or uncontrolled disease ；
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
- Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
- Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
- Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
- Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
- Allergic to the active ingredients or excipients of the study drug ；
- Unsuitable for the study or other chemotherapy determined by investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description envafolimab plus chemotherapy S1 Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W). envafolimab plus chemotherapy Oxaliplatin Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W). envafolimab plus chemotherapy Envafolimab Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W).
- Primary Outcome Measures
Name Time Method ORR 6 months Objective response rate
- Secondary Outcome Measures
Name Time Method PFS 6 months Progression Free Survival
OS 12 months Overall Survival
DCR 9 months Disease Control Rate
DOR 12 months Duration of Response
AEs 12 months Percentage of participants experiencing grade 3-5 adverse events
Qualify of Life 12 months Based on Quality of Life Questionnare-Core 30, evaluate the quality of life of patients
Trial Locations
- Locations (1)
Jiangsu Cancer Institute & Hospital
🇨🇳Nanjing, Jiangsu, China