Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence

  • STATUS
    Recruiting
  • End date
    Jun 10, 2026
  • participants needed
    240
  • sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
Updated on 10 February 2021
Investigator
EORTC HQ
Primary Contact
Cambridge University Hospital NHS (4.8 mi away) Contact
+24 other location

Summary

The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.

Other study objectives:

  • To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study
  • To correlate nutritional status assessment on outcomes and quality of life of patients

Details
Condition Gastric and Esophagogastric Junction Adenocarcinoma
Treatment Chemotherapy, Nivolumab and Ipilimumab
Clinical Study IdentifierNCT03443856
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last Modified on10 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically proven gastric, lower esophageal or GE-junction adenocarcinoma (Siewert I-III)
Subjects must have completed pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen and macroscopically complete surgery prior to randomization
Minimal duration of neoadjuvant chemotherapy should be 6 weeks, maximum 12 weeks
Total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis or McKeown oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled
Regardless of the type of surgery a minimum of 15 lymph nodes should have been resected and examined
Recovered from surgery and fit for study treatment as assessed by a multidisciplinary team. Surgery should have been completed 2 to 3 months before randomization
ypN1-3 status according to current (8th) version of TNM classification system. In case of an ypN0 status patients must meet the inclusion criterion of R1 resection
R0 or R1 resection according to current (8th) version of TNM classification system. In case of R0 resection, patients must meet the inclusion criterion of ypN1-3
WHO performance status score of 0 or 1
Age 18 years
Adequate organ function assessed within 7 days before randomization
White blood cell count (WBC) > 2 x 109/L
Absolute neutrophil count (ANC) > 1.5 x 109/L
Platelets 100 x 109/L
Hemoglobin 9 g/dL
Measured/calculated creatinine clearance 60 mL/min (according to Cockroft-Gault formula)
Total bilirubin within normal limits (if the patient has documented Gilbert's disease 1.5 ULN or direct bilirubin ULN)
Aspartate transaminase (AST) and alanine transaminase (ALT) 1.5ULN
Cardiac assessment by 12 Lead ECG and if clinically indicated, cardiac function assessment (using either echocardiography or MUGA scan)
All toxicities (exception alopecia) attributed to prior anti-cancer therapy must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to randomization
Men who are sexually active with an WOCBP must adhere to contraception (condom) during the study and for a period of 7 months after the last dose of the study treatment in the experimental arm and 6 months in the control arm
Patients of childbearing / reproductive potential should use highly effective method of birth control measures during the study treatment period and for at least 5 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria

R2 resection status
M1 stage according to current (8th) version of TNM classification system
Patients who have undergone complete resection of metastases
Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for postoperative chemotherapy or immunotherapy
Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry. Adequately treated cervical carcinoma in situ, and localized non-melanoma skin cancer are no exclusion criteria, regardless of timepoint of diagnosis
Subjects with active, known, or suspected infectious or autoimmune disease
Patients who have received antibiotics within the last 14 days before randomization are excluded
Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll
Subjects with a condition requiring systemic treatment with either corticosteroids ( 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration
Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Subjects with > Grade 1 peripheral neuropathy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Prior or concomitant treatment with radiotherapy/radiochemotherapy
Any positive test result for HBV or HCV indicating acute or chronic infection
Known history of HIV or known AIDS and, if required by local practice or positive HIV testing at screening
Known uncontrollable hypersensitivity to the components of cisplatin/oxaliplatin, fluorouracil (5-FU) or capecitabine, epirubicine or docetaxel
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note