> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-3-study-of-cadonilimab-combined-with-chemotherapy-vs-0ad7b84c-63fb-4c73-a1d0-8d376b8b189d > Record changed: 2026-11-04 # Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma NCT07700979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Participants 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Start date 2026-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) Number of sites 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Title and summary **Summary** The goal of this randomized, double-blind, multi-regional phase 3 study of cadonilimab combined with chemotherapy versus chemotherapy in combination with or without nivolumab for the first-line treatment of participants with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma trial is to compare OS between cadonilimab combined with chemotherapy and chemotherapy in combination with or without nivolumab in the ITT population. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Acronym** G/GEJ Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Short title** Phase 3 Study of Cadonilimab Combined With Chemotherapy vs Chemotherapy in Combination With or Without Nivolumab for the 1L Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric/GEJ Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Official title** A Randomized, Double-blind, Multi-regional Phase 3 Study of Cadonilimab Combined With Chemotherapy Versus Chemotherapy in Combination With or Without Nivolumab for the First-line Treatment of Participants With HER2-negative, Previously Untreated, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Dates **Completion date** 2030-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **First posted** 2026-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Registry last updated** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Primary completion date** 2029-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Start date** 2026-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Size and sites **Participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Planned participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Number of sites** 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Identifiers **Registry ID** NCT07700979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **ClinicalTrials.gov ID** NCT07700979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Outcomes ### Primary outcomes 1. Overall survival (OS) Timeframe: Approximately up to 14months Time from randomization to death from any cause ### Secondary outcomes 1. Progression-free survival(PFS) Timeframe: Approximately up to 8 months Time from the date of randomization to the date of progressive disease or death from any cause, whichever occurs first. 2. Objective response rate (ORR) Timeframe: Approximately up to 8 months 3. Disease control rate (DCR) Timeframe: Approximately up to 8 months 4. Duration of response (DoR) Timeframe: Approximately up to 8 months 5. Safety assessment Timeframe: Approximately up to 18 months Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Able to provide written informed consent and can understand and comply with the requirements of the study. 2. Histopathologically-confirmed diagnosis of locally advanced unresectable or metastatic G/GEJ adenocarcinoma. 3. No prior systemic therapy for locally advanced unresectable or metastatic G/GEJ adenocarcinoma. NOTE: For participants who have received prior neoadjuvant/adjuvant therapy for curative intent, the time between disease progression and last treatment should be at least 6 months. 4. ECOG PS of 0 or 1 within 3 days prior to randomization. 5. Age ≥ 18 years at the time of voluntarily signing informed consent. 6. Evaluable PD-L1 expression results. 7. Participants must have at least one measurable lesion per RECIST v1.1 as assessed by investigator assessment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 8. Adequate organ function as indicated by the following laboratory values. Specimens must be collected within 7 days prior to the first dose of study treatment. 9. Life expectancy ≥3 months. 10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment, and for at least 150 days after the last dose of cadonilimab/nivolumab, 270 days after the last dose of oxaliplatin, and 180 days after the last dose of capecitabine. 11. Non-sterile males must agree to use effective contraception during treatment and for at least 120 days following the last dose of cadonilimab/nivolumab/capecitabine and 180 days after the last dose of oxaliplatin. ### Exclusion criteria 1. Histopathologically confirmed other pathological types, such as squamous cell carcinoma, sarcoma or undifferentiated carcinoma. 2. Known HER2 positive. Be HER2-positive defined as either IHC 3+ or IHC 2+ in combination with ISH+ (or FISH). 3. Participants with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. 4. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1 time/month). 5. Clinically significant bleeding symptoms within 28 days before the first dose or a definite tendency to bleed. 6. Have a history of ≥ Grade 2 gastrointestinal perforation and/or fistulae (including prior gastric fistula operation) within 6 months prior to randomization. 7. Participants who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Sites - Mayo ClinicPhoenix, United StatesNot yet recruiting - UCLA HealthLos Angeles, United StatesNot yet recruiting - Rocky Mountain Cancer CentersDenver, United StatesNot yet recruiting - Yale School of MedicineNew Haven, United StatesNot yet recruiting - Dana Farber Cancer InstituteBoston, United StatesNot yet recruiting - Henry Ford HealthDetroit, United StatesNot yet recruiting - Mount SinaiNew York, United StatesNot yet recruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesNot yet recruiting - Oregon Health and Science UniversityPortland, United StatesNot yet recruiting - Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashville, United StatesNot yet recruiting - Baylor Scott & White HealthDallas, United StatesNot yet recruiting - MD Anderson Cancer CenterHouston, United StatesNot yet recruiting - University of Wisconsin Carbone Cancer CenterMadison, United StatesNot yet recruiting - Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNot yet recruiting - Peking University Cancer Hospital, Gastrointestinal Cancer Center IBeijing, ChinaRecruiting - Peking University Cancer Hospital, Gastrointestinal OncologyBeijing, ChinaNot yet recruiting - Guangdong Provincial People's HospitalGuangzhou, ChinaNot yet recruiting - Zhongshan Hospital Fudan UniversityShanghai, ChinaNot yet recruiting - Universitaetsklinikum EssenEssen, GermanyNot yet recruiting - University Cancer Center FrankfurtFrankfurt, GermanyNot yet recruiting - Universitätsmedizin der Johannes Gutenberg-UniversitätMainz, GermanyNot yet recruiting - Univerity MarburgMarburg, GermanyNot yet recruiting - Pratia MCM KrakówKrakow, PolandNot yet recruiting - Pratia PoznańPoznan, PolandNot yet recruiting - Narodowy Instytut Onkologii-im. Marii Sklodowskiej Curie Panstwowy Instytut Badawczy - w WarszawieWarsaw, PolandNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07700979) ## Related records ### Drugs (4) - [Cadonilimab](https://trialight.com/data/asset/cadonilimab-3970701f-ffc8-4027-a97b-4e6c913803e6.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Nivolumab](https://trialight.com/data/asset/nivolumab-d2e207ca-a7d1-43d0-987f-43ef7eef8f1b.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) ### Conditions (1) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) Primary condition ### Targets (3) - [CTLA4](https://trialight.com/data/target/ctla4-ba502748-1564-5251-a6a1-96e2f7035fe9.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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