Gastric / Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
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
DRUGAK104(SC)
AK104:subcutaneous injection
DRUGAK104(IV)
AK104:intravenous
DRUGCapecitabine
oral
intravenous
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 2. Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ). 3. Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. 4. Adequate organ and bone marrow function. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 6. Measurable disease by RECIST 1.1.
Exclusion criteria
1. 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. 2. Deep venous thrombosis within 3 months before first treatment. 3. Uncontrolled arterial hypertension. 4. Bleeding events within the last 1 months. 5. Prior treatment with immune checkpoint inhibitors. 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2). | up to 4 weeks | Measured serum trough concentration (Ctrough) of AK104 after the first administration (i.e., prior to dosing in Cycle 2). |
| Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration. | up to 4 weeks | Measured area under the concentration-time curve from 0 to 21 days of AK104 after the first administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | up to 24 months | Assessed by investigators |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to 24 months | Assessed by investigators |
| Progression-free survival (PFS) assessed by investigator per RECIST v1.1 | Up to 24 months | PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first. |
| Duration of Response (DOR) assessed by investigator per RECIST v1.1 | Up to 24 months | DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
| Time to Response (TTR) assessed by investigator per RECIST v1.1 | Up to 24 months | TTR refers to Time to Response. |
| Overall Survival | Up to 24 months | OS is defined as the time from randomization to death due to any cause. |
| Number of participants with adverse event (AE) | Up to 27 months | The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. |
Contacts
CONTACTTing Liu
PRINCIPAL_INVESTIGATORYanqiao Zhang
The Second Affiliated Hospital of Harbin Medical University
PRINCIPAL_INVESTIGATORTao Zhang
UNIVERSITY OF SCIENCE AND TECHNOLOGY UNION HOSPITAL TONG JI MEDICAL COLLEGE HUA ZHONG
Outcome results
None listed