- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05008783
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
April 2, 2024 updated by: Akeso
A Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for Locally Advanced Unresectable or G/GEJ Adenocarcinoma
A randomized, Double-blind, Multicenter, phase III Clinical Study of Comparing the Efficacy and Safety of AK104 Plus Oxaliplatin and Capecitabine (XELOX) Versus Placebo Plus XELOX as First-line Treatment for locally advanced Unresectable or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
610
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100143
- Peking University Cancer Hospital
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Fujian
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Fuzhou, Fujian, China, 350014
- Fujian Provincial Cancer Hospital
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Shanghai
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Shanghai, Shanghai, China, 200032
- Fudan University Cancer Hospital
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Shanghai, Shanghai, China, 20032
- Zhongshan Hospital, Fudan University
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Sichuan
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Chengdu, Sichuan, China, 610044
- West China Hospital of Sichuan University
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Yunnan
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Kunming, Yunnan, China, 650118
- Yunnan Cancer Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital of Zhejiang University Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be enrolled in the study:
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.
- Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.
- Unresectable locally advanced or metastatic gastric adenocarcinoma or GEJ adenocarcinoma.
- Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
- Subjects have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to participate in this study:
- Subjects with known HER2-positive gastric or GEJ adenocarcinoma.
- Histopathology or cytology confirmed other pathological types, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
- Subjects who received palliative local therapy for non-target lesions within 2 weeks prior to the first dose; systemic nonspecific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc.) within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 2 weeks prior to the first dose.
- Subjects who received any prior treatments targeting the mechanism of tumor immunity.
- Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose. If the perforation or fistula has been treated with resection or repair and the disease has recovered or resolved as judged by the Investigator, enrollment may be allowed.
- Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of cervix, carcinoma in situ of breast, localized prostate cancer, etc.
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AK104 + Oxaliplatin + Capecitabine
AK104 in combination with Oxaliplatin and Capecitabine
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AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) .
Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
Other Names:
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Placebo Comparator: Placebo + Oxaliplatin + Capecitabine
Placebo in combination with Oxaliplatin and Capecitabine
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Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) .
Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (os)
Time Frame: Up to 2 years
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OS in the ITT population.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTR
Time Frame: Up to 2 years
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TTR is defined as the time to response base on RECIST v1.1
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Up to 2 years
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AE
Time Frame: From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
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Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
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From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
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ORR
Time Frame: Up to 2 years
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ORR is the proportion of subjects with CR or PR based on RECIST v1.1
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Up to 2 years
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DCR
Time Frame: Up to 2 years
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DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
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Up to 2 years
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DoR
Time Frame: Up to 2 years
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DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
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Up to 2 years
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PFS
Time Frame: Up to 2 years
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1
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Up to 2 years
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Observed concentrations of AK104
Time Frame: From first dose of AK104 through the last dose of AK104, about average of 9 months.
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The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration
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From first dose of AK104 through the last dose of AK104, about average of 9 months.
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Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: From first dose of AK104 through 30 days after last dose of AK104
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The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
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From first dose of AK104 through 30 days after last dose of AK104
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiafu Ji, MD, Peking University Cancer Hospital & Institute
- Principal Investigator: Lin Shen, MD, Peking University Cancer Hospital & Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2021
Primary Completion (Estimated)
August 18, 2024
Study Completion (Estimated)
April 14, 2025
Study Registration Dates
First Submitted
July 30, 2021
First Submitted That Met QC Criteria
August 16, 2021
First Posted (Actual)
August 17, 2021
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK104-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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