Actively Recruiting
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Akeso · Updated on 2024-06-24
506
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.
CONDITIONS
Official Title
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older and 75 years or younger
- Histologically or cytologically confirmed advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
- At least one measurable disease based on RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Estimated survival of 3 months or more
- Adequate organ function as defined by protocol
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days after the last dose of study treatment
You will not qualify if you...
- Mixed gastric or gastroesophageal junction cancer containing other pathological components besides adenocarcinoma
- HER2-positive status
- Other invasive malignancies diagnosed within the past 3 years
- Currently participating in another interventional study
- Received systemic anti-tumor therapy within 4 weeks before randomization
- Previous systemic taxane treatment within 6 months before randomization
- Previous systemic treatment targeting VEGF or anti-VEGFR pathways
- Prior exposure to other immune checkpoint inhibitors or immune therapies besides anti-PD-(L)1 monoclonal antibody
- History of immune-related adverse effects preventing immunotherapy reintroduction or systemic therapy dependency on glucocorticoids or immunosuppressants within 14 days before randomization
- Severe infection within 4 weeks before randomization
- Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Serious hemorrhage or bleeding tendency within 2 months before randomization
- Major surgery or serious trauma within 28 days before randomization
- History of interstitial lung disease or noninfectious pneumonitis
- Active infections including tuberculosis, HIV, syphilis, or hepatitis B/C
- Known allergy to study drug antibodies or multiple substance allergies
- History of allogeneic organ or hematopoietic stem cell transplantation
- Toxicities from prior cancer therapy not resolved to Grade 1 or lower
- Use of live vaccines within 30 days before randomization
- Pregnant or lactating women
- Any condition deemed inappropriate for enrollment by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, China
Actively Recruiting
Research Team
T
Ting Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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