A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma 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: AK104(SC), AK104(IV), Capecitabine, Oxaliplatin injection.
- Who it may be relevant to
- Registry conditions: Gastric / 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
- Center list to be confirmed — check the primary protocol.
- 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, Open-Label, Multicenter, Phase I/III Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Overview
A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Interventions
- Drug AK104(SC)
AK104:subcutaneous injection - Drug AK104(IV)
AK104:intravenous - Drug Capecitabine
oral - Drug Oxaliplatin injection
intravenous
Primary outcome measures
- Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2). [Time frame: up to 4 weeks]
- Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration. [Time frame: up to 4 weeks]
Secondary outcome measures (7)
- Objective Response Rate (ORR) per RECIST 1.1 [Time frame: up to 24 months]
- Disease Control Rate (DCR) per RECIST 1.1 [Time frame: Up to 24 months]
- Progression-free survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Duration of Response (DOR) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Time to Response (TTR) assessed by investigator per RECIST v1.1 [Time frame: Up to 24 months]
- Overall Survival [Time frame: Up to 24 months]
- Number of participants with adverse event (AE) [Time frame: Up to 27 months]
Eligibility criteria
Inclusion criteria
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Adequate organ and bone marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Measurable disease by RECIST 1.1.
Exclusion criteria
- Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.
- Deep venous thrombosis within 3 months before first treatment.
- Uncontrolled arterial hypertension.
- Bleeding events within the last 1 months.
- Prior treatment with immune checkpoint inhibitors.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
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
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07449780 · AK104-SC-01