Gastroesophageal AdenocarcinomaPhase 2NCT07069712
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
A Phase 2 study testing Sonesitatug Vedotin, Rilvegostomig and Trastuzumab Deruxtecan (T-DXd) in people with Gastroesophageal Adenocarcinoma, run by AstraZeneca at 70 sites in 11 countries.
Trial summary
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- Sonesitatug Vedotin, Rilvegostomig and Trastuzumab Deruxtecan (T-DXd)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 70 sitesin 11 countries
- Study dates
- 17 Jul 2025to 16 Jul 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
- Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function
- Body weight > 35 kg
Who cannot join
- Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
- Central nervous system (CNS) pathology
- Uncontrolled infections
- Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
- History of another primary malignancy
Show all 9Show fewer
- Participants with any known or suspicious distant metastasis
- Uncontrolled hepatitis B and/or chronic or active hepatitis B
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Trial locations and contacts
70 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
70 sites in 11 countries
China12 sites, 11 recruiting
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Changchun, 130021
- Recruiting
Research Site
Changzhi, 046000
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chengdu, 610042
- Not yet recruiting
Research Site
Fuzhou, 350014
- Recruiting
Research Site
Hangzhou, 310003
- Recruiting
Research Site
Hangzhou, 310014
- Recruiting
Research Site
Kunming, 650118
- Recruiting
Research Site
Qingdao, 266003
- Recruiting
Research Site
Shanghai, 200025
- Withdrawn
Research Site
Shijiazhuang, 050020
Japan11 sites, 10 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Fukuoka, 812-8582
- Recruiting
Research Site
Hidaka-shi, 350-1298
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Kitaadachi-gun, 362-0806
- Recruiting
Research Site
Kōtoku, 135-8550
- Recruiting
Research Site
Nagoya, 464-8681
- Recruiting
Research Site
Osaka, 541-8567
- Withdrawn
Research Site
Osaka, 558-8558
- Recruiting
Research Site
Suita-shi, 565-0871
- Recruiting
Research Site
Yokohama, 241-8515
Italy9 sites, 8 recruiting
- Recruiting
Research Site
Florence, 50134
- Recruiting
Research Site
Milan, 20133
- Recruiting
Research Site
Milan, 20141
- Recruiting
Research Site
Milan, 20162
- Withdrawn
Research Site
Modena, 41124
- Recruiting
Research Site
Pisa, 56100
- Recruiting
Research Site
Rozzano, 20089
- Not yet recruiting
Research Site
Udine, 33100
- Recruiting
Research Site
Vicenza, 36100
Spain9 sites, 9 recruiting
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Barcelona, 08036
- Recruiting
Research Site
Elche, 03203
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Ourense, 32005
- Recruiting
Research Site
Oviedo, 33011
- Recruiting
Research Site
Santander, 39008
- Recruiting
Research Site
Valencia, 46010
United States7 sites, 5 recruiting
- Recruiting
Research Site
Fairway, Kansas, 66205
- Withdrawn
Research Site
New York, New York, 10032
- Completed
Research Site
New York, New York, 10065
- Recruiting
Research Site
Newark, Delaware, 19713
- Recruiting
Research Site
North Shores, Michigan, 49444
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
Washington D.C., District of Columbia, 20007
United Kingdom5 sites, 3 recruiting
- Withdrawn
Research Site
Bristol, BS2 8ED
- Recruiting
Research Site
Dundee, DD1 9SY
- Recruiting
Research Site
Headington, OX3 7LJ
- Withdrawn
Research Site
London, E1 1BB
- Recruiting
Research Site
Norwich, NR4 7UY
Georgia4 sites, 4 recruiting
- Recruiting
Research Site
Tbilisi, 0112
- Recruiting
Research Site
Tbilisi, 0114
- Recruiting
Research Site
Tbilisi, 0144
- Recruiting
Research Site
Tbilisi, 0159
Taiwan4 sites, 4 recruiting
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Tainan, 704
- Recruiting
Research Site
Taipei, 11217
- Recruiting
Research Site
Taoyuan, 33305
Turkey (Türkiye)4 sites
- Withdrawn
Research Site
Adapazarı, 54100
- Withdrawn
Research Site
Erzurum, 25240
- Withdrawn
Research Site
Fatih-Istanbul, 34098
- Withdrawn
Research Site
Istanbul, 34722
Canada3 sites, 2 recruiting
- Recruiting
Research Site
Montreal, Quebec, H2X 3E4
- Recruiting
Research Site
Montreal, Quebec, H4A 3J1
- Withdrawn
Research Site
Toronto, Ontario, M5G 2M9
Poland2 sites
- Withdrawn
Research Site
Bialystok, 15-027
- Withdrawn
Research Site
Warsaw, 02-034
About this study
Official title: A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.
Read the detailed description
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies/cohorts, each allows the assessment of multiple novel agents or novel combinations.
Participants will be assigned across different sub-studies/cohorts, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study/cohort.
- Conditions
- Gastroesophageal Adenocarcinoma
- Being tested
- Sonesitatug Vedotin, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, 5-Fluorouracil (5-FU)
- Keywords
- Locally Advanced Resectable Gastroesophageal Adenocarcinoma, Gastroesophageal Junction, Neoadjuvant Treatment, Perioperative Treatment, Gastric cancer, Immune checkpoint inhibitors, Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonesitatug VedotinDrug
Also called AZD0901
Sonesitatug Vedotin will be administered as an IV infusion.
RilvegostomigDrug
Also called AZD2936
Rilvegostomig will be administered as an IV infusion.
Trastuzumab Deruxtecan (T-DXd)Drug
Also called DS-8201a
T-DXd will be administered as an IV infusion.
CapecitabineDrug
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-Fluorouracil (5-FU)Drug
5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care.
FLOT ChemotherapyDrug
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Calcium folinateDrug
Also called Leucovorin
Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or Capecitabine | Experimental | Participants will receive Sonesitatug Vedotin (Dose A) plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose A) plus Rilvegostomig as adjuvant therapy 2. Receives: Drug: Sonesitatug Vedotin; Drug: Rilvegostomig; Drug: Capecitabine; Drug: 5-Fluorouracil (5-FU) |
| Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or Capecitabine | Experimental | Participants will receive T-DXd plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2. Receives: Drug: Rilvegostomig; Drug: Trastuzumab Deruxtecan (T-DXd); Drug: Capecitabine; Drug: 5-Fluorouracil (5-FU) |
| Sub-study 3: Rilvegostomig plus FLOT chemotherapy | Experimental | Participants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2. Receives: Drug: Rilvegostomig; Drug: FLOT Chemotherapy |
| Sub-study 1: Cohort 1b - Sonesitatug Vedotin plus Rilvegostomig and Capecitabine | Experimental | Participants will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig and Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig as adjuvant therapy 2. Receives: Drug: Sonesitatug Vedotin; Drug: Rilvegostomig; Drug: Capecitabine |
| Sub-study 1: Cohort 1c - Sonesitatug Vedotin plus Rilvegostomig plus 5-FU and calcium folinate | Experimental | Participants will receive Sonesitatug Vedotin (Dose C) plus Rilvegostomig plus 5-FU and calcium folinate as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose C) plus Rilvegostomig as adjuvant therapy 2. Receives: Drug: Sonesitatug Vedotin; Drug: Rilvegostomig; Drug: 5-Fluorouracil (5-FU); Drug: Calcium folinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of perioperative treatment.
Measured: Until sub-study completion, up to 38 months
Percentage of participants with pathological complete response (pCR)
pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.
Measured: Until sub-study completion, up to 38 months
Secondary outcomes (9)
Surgery completion rate
Surgery completion rate is defined as the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy.
Measured: Until sub-study completion, up to 38 months
R0 resection (complete resection) rate
R0 resection (complete resection) rate is the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy and had a confirmed margin-negative resection.
Measured: Until sub-study completion, up to 38 months
Percentage of participants with tumor downstaging
Tumor downstaging is defined as the lowering of the primary tumor (T) and/or regional lymph nodes (N) from pre-neoadjuvant clinical staging (pre-cTN) to post-neoadjuvant clinical staging (post-cTN) and to postoperative pathological staging (ypTN).
Measured: Until sub-study completion, up to 38 months
Event-free survival (EFS)
EFS is defined as the time from the first dose of study intervention to documented Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or non-RECIST 1.1 disease progression that precludes radical surgery or requires non-protocol therapy during the neoadjuvant through surgery period, or to documented RECIST 1.1 or biopsy-confirmed non-RECIST 1.1 recurrence or progression of disease during the adjuvant period, or death due to any cause at any time.
Measured: Until sub-study completion, up to 38 months
Disease-free survival (DFS)
DFS is defined as the time elapsed from the date of the first post-surgery scan (ie, Adjuvant Baseline scan) until the date of first evidence of disease recurrence as determined by Investigator using RECIST 1.1 assessment (local or distant), or death due to any cause, whichever occurs first.
Measured: Until sub-study completion, up to 38 months
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a CR or PR as determined by Investigator using RECIST 1.1 at their latest assessment prior to surgery.
Measured: Until sub-study completion, up to 38 months
Overall survival (OS)
OS is defined as the time from the first dose of the study intervention until the date of death due to any cause regardless of whether participant withdraws from treatment or receives another anti-cancer therapy.
Measured: Until sub-study completion, up to 38 months
Serum concentrations of study interventions
To assess the serum concentrations of study interventions in participants receiving perioperative treatment.
Measured: Until sub-study completion, up to 38 months
Number of participants with positive anti-drug antibodies (ADA)
To assess the immunogenicity of study interventions in participants receiving perioperative treatment.
Measured: Until sub-study completion, up to 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start17 Jul 2025
- Primary completion9 Nov 2027 (estimated)
- Study completion16 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069712
- Sponsor's protocol ID
- D9804C00001
- Other IDs
- 2024-516909-23-00
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.