Recruiting NCT06341335
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cadonilimab, pulocimab, paclitaxel, placebo.
- Who it may be relevant to
- Registry conditions: Gastric and Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy
Overview
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.
Interventions
- Drug cadonilimab
iv, q3w - Drug pulocimab
iv, q3w - Drug paclitaxel
iv, q3w - Drug placebo
iv, q3w
Primary outcome measures
- Progression-free survival (PFS) assessed by blinded independent central review (BICR) [Time frame: Up to 2 years]
- Overall survival (OS) [Time frame: Up to 2 years]
Secondary outcome measures (4)
- Progression-free survival (PFS) assessed by investigator [Time frame: Up to 2 years]
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Duration of Response (DoR) [Time frame: Up to 2 years]
- Disease control rate (DCR) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- Signed informed consent
- Age ≥ 18 years and ≤ 75 years
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
- At least one measurable disease based on RECIST v1.1
- ECOG status of 0 or 1
- Estimated survival ≥ 3 months
- Adequate organ function per protocol-defined criteria
- Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
Exclusion criteria
- Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
- HER2-positive
- Known other invasive malignancies within 3 years
- Subjects who are currently participating in other interventional study
- Received prior systemic anti-tumour therapy within 4 weeks before randomization
- Previous systemic treatment with taxane within 6 months before randomization
- Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
- In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
- History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
- History of severe infection within 4 weeks prior to randomization
- Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
- Major surgical procedure or serious trauma within 28 days prior to randomization
- History of interstitial lung disease or noninfectious pneumonitis
- Active infectious diseases, including tuberculosis, HIV infection, syphilis infection，or hepatitis B/C
- Known allergy to the antibody or any component of the study drug; Or the constitution of being allergic to multiple substances
- History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
- Use of live vaccines within 30 days prior to randomization
- Pregnant or lactating women.
- Any condition considered by the investigator to be inappropriate for enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital & Institute — Beijing
Identifiers
NCT: NCT06341335 · AK109-301