A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD0901, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, China, Georgia, Italy +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Detailed description
This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations.
Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.
Interventions
- Drug AZD0901
AZD0901 will be administered as an IV infusion. - Drug Rilvegostomig
Rilvegostomig will be administered as an IV infusion. - Drug Trastuzumab Deruxtecan (T-DXd)
T-DXd will be administered as an IV infusion. - Drug Capecitabine
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care. - Drug 5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care. - Drug FLOT Chemotherapy
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Primary outcome measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: Until sub-study completion, up to 38 months]
- Percentage of participants with pathological complete response (pCR) [Time frame: Until sub-study completion, up to 38 months]
Secondary outcome measures (9)
- Surgery completion rate as planned [Time frame: Until sub-study completion, up to 38 months]
- R0 resection (complete resection) rate as planned [Time frame: Until sub-study completion, up to 38 months]
- Percentage of participants with tumor downstaging [Time frame: Until sub-study completion, up to 38 months]
- Event-free survival (EFS) [Time frame: Until sub-study completion, up to 38 months]
- Disease-free survival (DFS) [Time frame: Until sub-study completion, up to 38 months]
- Objective response rate (ORR) [Time frame: Until sub-study completion, up to 38 months]
- Overall survival (OS) [Time frame: Until sub-study completion, up to 38 months]
- Serum concentrations of study interventions [Time frame: Until sub-study completion, up to 38 months]
- Number of participants with positive anti-drug antibodies (ADA) [Time frame: Until sub-study completion, up to 38 months]
Eligibility criteria
Inclusion criteria
- Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
- Participants who are CLDN18.2-positive and HER2-negative 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 12 centers
- Research Site — Beijing
- Research Site — Changchun
- Research Site — Changzhi
- Research Site — Chengdu
- Research Site — Chengdu
- Research Site — Fuzhou
- Research Site — Hangzhou
- Research Site — Hangzhou
- … and 4 more centers
Japan · 11 centers
- Research Site — Chūōku
- Research Site — Fukuoka
- Research Site — Hidaka-shi
- Research Site — Kashiwa
- Research Site — Kitaadachi-gun
- Research Site — Kōtoku
- Research Site — Nagoya
- Research Site — Osaka
- … and 3 more centers
Italy · 9 centers
- Research Site — Florence
- Research Site — Milan
- Research Site — Milan
- Research Site — Milan
- Research Site — Modena
- Research Site — Pisa
- Research Site — Rozzano
- Research Site — Udine
- … and 1 more center
Spain · 9 centers
- Research Site — Barcelona
- Research Site — Barcelona
- Research Site — Elche
- Research Site — Madrid
- Research Site — Málaga
- Research Site — Ourense
- Research Site — Oviedo
- Research Site — Santander
- … and 1 more center
United States · 7 centers
- Research Site — Newark
- Research Site — Washington D.C.
- Research Site — Fairway
- Research Site — North Shores
- Research Site — New York
- Research Site — New York
- Research Site — Pittsburgh
United Kingdom · 5 centers
- Research Site — Bristol
- Research Site — Dundee
- Research Site — Headington
- Research Site — London
- Research Site — Norwich
Georgia · 4 centers
- Research Site — Tbilisi
- Research Site — Tbilisi
- Research Site — Tbilisi
- Research Site — Tbilisi
Taiwan · 4 centers
- Research Site — Kaohsiung City
- Research Site — Tainan
- Research Site — Taipei
- Research Site — Taoyuan
Turkey (Türkiye) · 4 centers
- Research Site — Adapazarı
- Research Site — Erzurum
- Research Site — Fatih-Istanbul
- Research Site — Istanbul
Canada · 3 centers
- Research Site — Toronto
- Research Site — Montreal
- Research Site — Montreal
Poland · 2 centers
- Research Site — Bialystok
- Research Site — Warsaw
Identifiers
NCT: NCT07069712 · D9804C00001 · 2024-516909-23-00