Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Envafolimab and Lenvatinib Combined With Paclitaxel-albumin

NCT06030934 | Unknown Phase 2

• 1 other identifier: SMA-GC-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open, exploratory clinical study. Eligible patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma signed an informed consent form, were screened for enrollment, and were entered into Group A (non-immune retreatment group-patients who had failed previous first-line treatment with standard chemotherapy) and Group B (immune retreatment-patients who had obtained SD and above with best efficacy of previous first-line treatment with PD-1 antibody) based on whether they had received previous first-line treatment with PD-1 antibody. All patients received a combination of envafolimab and lenvatinib in combination with paclitaxel-albumin and were treated until disease progression, withdrawal of informed consent by the subject, loss to follow-up, and death, where treatment did not exceed 2 years. Clinical oncologic imaging assessments were performed using iRECIST every 8 weeks during treatment; safety assessments were performed using CTCAE 5.0, and adverse events were recorded throughout the study up to 30 days after the end of treatment.

Conditions

Gastric / Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants with measurable lesions achieving a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

  12 months

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  12 months

• Disease Control Rate (DCR)

  12 months

• Duration of Response (DoR)

  12 months

• Overall Survival (OS)

  20 months

• Adverse Events (AEs)

  12 months

Study Arms (2)

Patients who have failed previous standard chemotherapy

EXPERIMENTAL

Drug: envafolimab and lenvatinib combined with paclitaxel-albumin

Patients with SD or above obtained by previous first-line PD-1 antibody therapy

EXPERIMENTAL

Drug: envafolimab and lenvatinib combined with paclitaxel-albumin

Interventions

envafolimab and lenvatinib combined with paclitaxel-albumin DRUG

envafolimab: 200mg d1,15 s.c. Q4W; lenvatinib: 8mg (\<60kg) or 12mg (≥60kg) p.o. Q.d.; paclitaxel-albumin: 100 mg/m2 d1,8,15 stop for one week, i.v. Q4W

Patients who have failed previous standard chemotherapy; Patients with SD or above obtained by previous first-line PD-1 antibody therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to enrollment.
• Age 18-80 years.
• Negative for HER2
• Diagnosis confirmed by histological examination and/or cytological examination combined with imaging assessment of advanced metastatic gastric/gastroesophageal junction adenocarcinoma.
• Failure of previous first-line therapy. Group A (non-immune retreatment): patients who have failed prior chemotherapy with first-line standard therapy. Group B (immune retreatment): patients who received previous first-line PD-1 antibody therapy with optimal efficacy SD and on.
• ECOG score: 0 to 1.
• At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to iRECIST criteria).
• Adequate organ function with.
• Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelets (Platelet, PLT) ≥ 70 × 109/L, Hemoglobin (HGB) ≥ 90 g/L.
• Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled.
• Renal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (applying the standard Cockcroft-Gault formula).
• Coagulation function: International Normalized Ratio (INR) ≤ 1.5 /PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, as long as PT and INR are within the range drawn up by anticoagulant drugs.
• A predicted survival of ≥ 3 months.
• Female patients must be non-pregnant and non-lactating and are required to use a medically approved form of contraception (e.g., IUD, pill or condom) during study treatment and for at least 120 days after study completion, and are not allowed to donate eggs to another person or freeze them for fertilization and propagation during this period.

You may not qualify if:

• Symptomatic brain metastases.
• Known MSI-H/dMMR.
• A prior history of a primary tumor outside of the gastric/gastroesophageal junction
• Active autoimmune disease or autoimmune disease with potential for recurrence such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subjects with vitiligo or complete remission of asthma in childhood and adult who do not require any intervention afterwards can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
• Subjects with any severe and/or uncontrolled disease. including.
• Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \[FBG\] \> 10 mmol/L)
• Having ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification)
• Active or uncontrolled severe infection (≥ CTCAE grade 2 infection) requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection
• Those with renal failure requiring hemodialysis or peritoneal dialysis.
• Those with a history of immunodeficiency, including HIV-positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
• Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study treatment, except for replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency); receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Doses \>10 mg/day of prednisone or other equivalent hormone and within 2 weeks of the first dose and still continuing
• Those with a history of active tuberculosis
• Those who fail to control and still require repeated drainage of ascites, pericardial effusion, pleural effusion.
• Research treatment related to.
• Patients who have undergone major organ transplantation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

envafolimab

Study Officials

• Weijian Guo, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Gastrointestinal Oncology

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 11, 2023
• Study Start: October 24, 2022
• Primary Completion: November 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)