Actively Recruiting
Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin
Led by Fudan University · Updated on 2024-05-09
40
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, two-arm exploratory Phase II clinical trial aimed at observing and evaluating the efficacy and safety of combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin as second-line treatment for advanced gastric/esophagogastric junction adenocarcinoma. Patients meeting the inclusion criteria were divided into two groups based on whether they had received PD-1/L1 antibody treatment in the first line: Group A (immunotherapy-naive group - patients who had previously failed standard chemotherapy in the first line) and Group B (immunotherapy rechallenge group - patients who had previously failed PD-1/L1 antibody combined chemotherapy in the first line). All patients received combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin until intolerable toxic reactions occurred, disease progression, withdrawal of informed consent by the subject, loss to follow-up, death, other conditions judged by the investigator to require termination of treatment, or termination of the study, whichever occurred first. The maximum duration of paclitaxel-albumin treatment was 6 cycles, and cadonilimab treatment did not exceed 1 year. Clinical tumor imaging evaluations were conducted every 8 weeks during treatment using RECIST v1.1 criteria, and safety assessments were performed using CTCAE 5.0, recording adverse events within 30 days from the first dose to the end of treatment.
CONDITIONS
Official Title
Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before joining the study
- Age between 18 and 80 years
- Negative for HER2
- Diagnosed with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by tissue or cytology plus imaging
- Failed previous first-line therapy
- Group A: no prior immunotherapy, failed standard chemotherapy
- Group B: failed PD-1/L1 antibody combined chemotherapy in first-line
- ECOG performance status of 0 to 1
- At least one measurable lesion by CT scan according to iRECIST
- Adequate blood counts: ANC 2 1.5 x 10^9/L, platelets 2 100 x 10^9/L, hemoglobin 2 90 g/L
- Adequate liver function within specified limits after stable hepatoprotective treatment
- Renal function with creatinine 2 1.5 x ULN or clearance 2 50 mL/min
- Coagulation within defined INR, PT, and aPTT limits
- Predicted survival of at least 3 months
- Female patients must not be pregnant or breastfeeding and must use approved contraception during and 120 days after treatment
- Female patients cannot donate eggs or freeze them during the study and 120 days after
You will not qualify if you...
- Symptomatic brain metastases
- Known MSI-H or dMMR status
- History of a primary tumor outside the gastric/gastroesophageal junction within 3 years
- Active or potentially recurring autoimmune diseases requiring treatment, except vitiligo or controlled asthma
- Severe or uncontrolled diseases including poorly controlled blood pressure or diabetes
- Significant heart conditions including myocardial ischemia, infarction, arrhythmia, or heart failure
- Active severe infections requiring systemic therapy
- Active hepatitis or uncontrolled chronic hepatitis B or C outside defined viral load limits
- Renal failure requiring dialysis
- History of immunodeficiency or organ transplantation
- Recent systemic immunosuppressive therapy or glucocorticoids above specified doses
- History of active tuberculosis
- Uncontrolled fluid accumulations like ascites, pericardial or pleural effusion
- Recent major surgery, incisional biopsy, trauma, or untreated wounds
- Recent live attenuated vaccination
- History of severe allergic reactions to monoclonal antibodies or study drugs
- Participation in other clinical trials within 4 weeks prior
- Prior first-line treatment with taxanes, anti-angiogenic agents, or dual immunotherapy
- Severe allergies
- Pregnancy or breastfeeding
- Bleeding risk or coagulation disorders
- History of psychotropic substance abuse or psychiatric disorders interfering with study
- Any condition judged by investigator to endanger safety or study completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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