- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04221555
Trial of Neoadjuvant Durvalumab Plus Docetaxel, Oxaliplatin, S-1 Followed by Surgery and Adjuvant Durvalumab Plus S-1 Chemotherapy in Potentially Resectable MMR Proficient Gastric or Gastroesophageal Junction Adenocarcinoma
Neoadjuvant Durvalumab (MEDI4736) Plus Docetaxel, Oxaliplatin, S-1 (DOS) Followed by Surgery and Adjuvant Durvalumab Plus S-1 Chemotherapy in Potentially Resectable MMR Proficient (pMMR) Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Treatment for the main treatment group (pMMR tumor)
- Neoadjuvant treatment Durvalumab 1120 mg IV on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles.
- Surgery
- Adjuvant treatment After 4-6 weeks from surgery, S-1 40 mg/m2 bid orally on D1-28 plus durvalumab 1120 mg on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.
Treatment for the exploratory group (dMMR tumor)
- Neoadjuvant treatment Durvalumab 1500 mg IV and tremelimumab 75 mg IV on D1 will be administered every four weeks for three cycles.
- Surgery
- Adjuvant treatment After 4-6 weeks from surgery, durvalumab 1500 mg on D1 will be administered every 4 weeks for 12 months as an adjuvant treatment.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Min-Hee Ryu, MD, PhD
- Phone Number: +82-2-3010-5935
- Email: miniryu@amc.seoul.kr
Study Contact Backup
- Name: Hyung-Don Kim, MD, PhD
- Phone Number: +82-2-3010-5935
- Email: kimhdmd@amc.seoul.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Asan Medical Center
-
Contact:
- Min-Hee Ryu, MD, PhD
- Phone Number: 82-2-3010-5935
- Email: miniryu@amc.seoul.kr
-
Contact:
- MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed pathologically proven potentially resectable gastric or GEJ adenocarcinoma
- Clinical stages of T3-4N0 or T2-4N+ according to the American Joint Committee on Cancer (AJCC) 8th edition by computed tomography (CT)
- Microsatellite-instability (MSI) status determined by immunohistochemical (IHC) staining
- No peritoneal seeding identified by laparoscopy if suspected by CT
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Age > 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of > 12 months
- Body weight > 30kg
- No existing neuropathy
Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
- Platelet count ≥100 (or 75) x 109/L (>75,000 per mm3)
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN
- Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Exclusion Criteria:
- Participation in another clinical study with an investigational product during the last 2 weeks
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacementtherapy) is acceptable
- Major surgical procedure within 28 days prior to the first dose of durvalumab
- Distant metastasis including M1 lymph node
- Unable to take medication orally
- Gastric outlet obstruction and/or severe gastrointestinal bleeding
Impaired bowel absorption, including any of the following:
- Bowel obstruction
- Chronic inflammatory bowel disease
- History of extended bowel resection
- Gastric dumping syndrome
- History of allogenic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Prior randomisation or treatment in a previous durvalumab or tremelimumab clinical study regardless of treatment arm assignment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: the main treatment group
pMMR tumor
|
|
Active Comparator: the exploratory group
dMMR tumor
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathologic complete regression (pCR) rate
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
R0 resection rate
Time Frame: 3 years
|
3 years
|
Disease free survival (DFS)
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Min-Hee Ryu, MD, PhD, Asan Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Adenocarcinoma
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Docetaxel
- Oxaliplatin
- Durvalumab
- Tremelimumab
- Antibodies, Monoclonal
Other Study ID Numbers
- AMC2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
-
AkesoRecruitingResectable Gastric or Gastroesophageal Junction AdenocarcinomaChina
-
M.D. Anderson Cancer CenterRecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedClinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Postneoadjuvant... and other conditionsUnited States
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Korea, Republic of, China, Spain, Taiwan, Japan, Argentina, Canada, Croatia, Greece, Ireland, Malaysia, Netherlands, Portugal, Romania, Thailand, Turkey, United Kingdom
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Spain, Taiwan, United Kingdom
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage 0 Gastric... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingPeritoneal Carcinomatosis | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma... and other conditionsUnited States
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Active, not recruitingGastric or Gastroesophageal Junction CancerChina
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric... and other conditionsUnited States
Clinical Trials on Docetaxel, Oxaliplatin, S-1 and Durvalumab
-
Lin ChenUnknownGastric AdenocarcinomaChina
-
Sun Yat-sen UniversityUnknown
-
Peking University Cancer Hospital & InstituteRecruiting
-
SanofiCompletedGastric CancerKorea, Republic of
-
Hallym University Medical CenterSanofi; Asan Medical CenterCompletedStomach NeoplasmsKorea, Republic of
-
Fudan UniversityTerminated
-
Asan Medical CenterRecruiting
-
Sixth Affiliated Hospital, Sun Yat-sen UniversitySun Yat-sen UniversityRecruitingChemotherapy Effect | Locally Advanced Gastroesophageal Junction AdenocarcinomaChina
-
Peking UniversityTaiho Pharmaceutical Co., Ltd.UnknownPancreatic Cancer | Biliary Tract Cancer | Periampullary AdenocarcinomaChina
-
Chinese PLA General HospitalUnknown