Actively Recruiting
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)
Led by AstraZeneca · Updated on 2026-05-18
100
Participants Needed
70
Research Sites
83 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of new drugs or drug combinations given around the time of surgery in adults with locally advanced gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not been treated before. This phase II, open-label study includes multiple sub-studies to assess different novel treatments. Participants are assigned to sub-studies based on the recommended dose determined by a safety review. Participants receive one of three treatment plans that combine novel drugs and chemotherapy before surgery (neoadjuvant) and after surgery (adjuvant). One group receives AZD0901 plus Rilvegostomig with either 5-FU or Capecitabine; another receives Trastuzumab Deruxtecan (T-DXd) plus Rilvegostomig with 5-FU or Capecitabine; the third group receives Rilvegostomig plus FLOT chemotherapy. After initial combination therapy, all groups continue with Rilvegostomig alone in the adjuvant phase. Treatments are given through intravenous infusions or orally, depending on the drug. During the study, participants undergo surgery as planned and are monitored for side effects, tumor response, and survival outcomes up to 38 months. Researchers collect data on adverse events, tumor shrinkage, surgery success rates, event-free and disease-free survival, and overall survival. Blood samples are taken to measure drug levels and immune responses. Participants are followed closely to assess treatment safety and effectiveness throughout the study period.
CONDITIONS
Brief Title
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically documented gastric, gastroesophageal junction, or esophageal adenocarcinoma with resectable disease
- CLDN18.2-positive and HER2-negative for Sub-study 1 or HER2-positive for Sub-study 2; no specific biomarker requirements for Sub-study 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function
- Body weight greater than 35 kg
- Age 18 years or older
You will not qualify if you...
- Prior anti-cancer treatment or surgery for current gastric, gastroesophageal junction, or esophageal cancer
- Active or prior autoimmune or inflammatory disorders requiring systemic steroids or immunosuppressive treatment
- Central nervous system pathology
- Uncontrolled infections
- History or current interstitial lung disease (ILD) or pneumonitis
- History of another primary malignancy
- Known or suspected distant metastasis
- Uncontrolled or chronic active hepatitis B
- Use of immunosuppressive medication within 14 days before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 38 months
Participants receive neoadjuvant combination therapy before surgery, followed by surgery, then adjuvant combination therapy and adjuvant monotherapy as perioperative treatment.
Visits occur regularly during pre-surgery and post-surgery treatment phases
Duration - Up to 38 months
Participants are monitored for safety, treatment effects, and survival outcomes after completion of perioperative treatment.
Periodic visits for assessments
Trial Site Locations
Total: 70 locations
1
Research Site
Newark, Delaware, United States, 19713
Actively Recruiting
2
Research Site
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
Research Site
Fairway, Kansas, United States, 66205
Actively Recruiting
4
Research Site
North Shores, Michigan, United States, 49444
Actively Recruiting
5
Research Site
New York, New York, United States, 10032
Not Yet Recruiting
6
Research Site
New York, New York, United States, 10065
Actively Recruiting
7
Research Site
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
8
Research Site
Toronto, Ontario, Canada, M5G 2M9
Suspended
9
Research Site
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
10
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
11
Research Site
Beijing, China, 100142
Actively Recruiting
12
Research Site
Changchun, China, 130021
Actively Recruiting
13
Research Site
Changzhi, China, 046000
Actively Recruiting
14
Research Site
Chengdu, China, 610041
Actively Recruiting
15
Research Site
Chengdu, China, 610042
Actively Recruiting
16
Research Site
Fuzhou, China, 350014
Not Yet Recruiting
17
Research Site
Hangzhou, China, 310003
Actively Recruiting
18
Research Site
Hangzhou, China, 310014
Actively Recruiting
19
Research Site
Kunming, China, 650118
Actively Recruiting
20
Research Site
Qingdao, China, 266003
Actively Recruiting
21
Research Site
Shanghai, China, 200025
Actively Recruiting
22
Research Site
Shijiazhuang, China, 050020
Withdrawn
23
Research Site
Tbilisi, Georgia, 0112
Actively Recruiting
24
Research Site
Tbilisi, Georgia, 0114
Actively Recruiting
25
Research Site
Tbilisi, Georgia, 0144
Actively Recruiting
26
Research Site
Tbilisi, Georgia, 0159
Actively Recruiting
27
Research Site
Florence, Italy, 50134
Actively Recruiting
28
Research Site
Milan, Italy, 20133
Actively Recruiting
29
Research Site
Milan, Italy, 20141
Actively Recruiting
30
Research Site
Milan, Italy, 20162
Actively Recruiting
31
Research Site
Modena, Italy, 41124
Withdrawn
32
Research Site
Pisa, Italy, 56100
Actively Recruiting
33
Research Site
Rozzano, Italy, 20089
Actively Recruiting
34
Research Site
Udine, Italy, 33100
Not Yet Recruiting
35
Research Site
Vicenza, Italy, 36100
Actively Recruiting
36
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
37
Research Site
Fukuoka, Japan, 812-8582
Actively Recruiting
38
Research Site
Hidaka-shi, Japan, 350-1298
Actively Recruiting
39
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
40
Research Site
Kitaadachi-gun, Japan, 362-0806
Actively Recruiting
41
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
42
Research Site
Nagoya, Japan, 464-8681
Actively Recruiting
43
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
44
Research Site
Osaka, Japan, 558-8558
Withdrawn
45
Research Site
Suita-shi, Japan, 565-0871
Actively Recruiting
46
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
47
Research Site
Bialystok, Poland, 15-027
Withdrawn
48
Research Site
Warsaw, Poland, 02-034
Withdrawn
49
Research Site
Barcelona, Spain, 08035
Actively Recruiting
50
Research Site
Barcelona, Spain, 08036
Actively Recruiting
51
Research Site
Elche, Spain, 03203
Actively Recruiting
52
Research Site
Madrid, Spain, 28007
Actively Recruiting
53
Research Site
Málaga, Spain, 29010
Actively Recruiting
54
Research Site
Ourense, Spain, 32005
Actively Recruiting
55
Research Site
Oviedo, Spain, 33011
Actively Recruiting
56
Research Site
Santander, Spain, 39008
Actively Recruiting
57
Research Site
Valencia, Spain, 46010
Actively Recruiting
58
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
59
Research Site
Tainan, Taiwan, 704
Actively Recruiting
60
Research Site
Taipei, Taiwan, 11217
Actively Recruiting
61
Research Site
Taoyuan, Taiwan, 33305
Actively Recruiting
62
Research Site
Adapazarı, Turkey (Türkiye), 54100
Withdrawn
63
Research Site
Erzurum, Turkey (Türkiye), 25240
Withdrawn
64
Research Site
Fatih-Istanbul, Turkey (Türkiye), 34098
Withdrawn
65
Research Site
Istanbul, Turkey (Türkiye), 34722
Withdrawn
66
Research Site
Bristol, United Kingdom, BS2 8ED
Withdrawn
67
Research Site
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
68
Research Site
Headington, United Kingdom, OX3 7LJ
Actively Recruiting
69
Research Site
London, United Kingdom, E1 1BB
Not Yet Recruiting
70
Research Site
Norwich, United Kingdom, NR4 7UY
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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