Trials Sponsors Conditions Drugs Pricing

Conditions

stomach cancer Esophage gastro-oesophageal junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

The primary endpoint is the percentage of patients alive without progression at 6 months (PFS at 6 months) after the randomization. Progression is defined as radiological progression according to RECIST version 1.1 criteria from morphological assessment, according to the investigator, or death, whatever the reason (which occurs first).

Secondary Outcomes (6)

Overall survival (OS): OS is defined by the time between the date of randomization and the date of death (regardless of the cause). Alive patients will be censored at the date of their last news.
Time To Progression (TTP): This time is defined by the time between the date of randomization and the date of the first radiological progression (according to RECIST v1.1) according to the investigator or death linked to cancer (which occurs first). Patients alive without radiological progression will be censored on the date of their latest CT-scan. Patients who died for other reason than cancer will be censored at the date of death
Progression-Free Survival (PFS): PFS is defined as the time between randomization and first radiological progression (according to RECIST 1.1) or death (whatever the cause). Patients alive without progression will be censored at the date of last news. Median PFS is evaluated as secondary endpoint.
Best Objective Response Rate: It is the percentage of patients with Objective Response (OR) at the best response evaluation during the treatment according to RECIST v1.1 according to the investigator. The objective response is defined as partial or complete response. Patients without imaging or non-evaluable imaging will not be taken into account in the analysis.
Safety profile: Adverse events (AE) will be evaluated according to NCI-CTC v5.0. All grade and severe (grade 3-5) AE will be recorded until 4 months after the last administration of treatment.
+1 more secondary outcomes

Interventions

IRINOTECANType not reported

FOLINIC ACIDType not reported

FLUOROURACILType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
IRINOTECAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
FOLINIC ACID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry record
Formulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry record
Formulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

IRINOTECAN
Named ingredient: Irinotecan
View registry record
FOLINIC ACID
Named ingredient: Folinic Acid
View registry record
FLUOROURACIL
Named ingredient: Fluorouracil
View registry record
FLUOROURACIL
Named ingredient: Fluorouracil
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
At least one measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1 criteria
World Health Organization (WHO) performance status 0-1

Sponsors & Collaborators

Fondation Franc.Cancerologie Digestive
Type not reportedlead

Study Sites (29)

CHRU Nancy Brabois

Vandoeuvre les Nancy, 54511, France

Marie MULLER+33383153354 m.muller7@chru-nancy.fr

Hospices Civils De Lyon

Lyon Cedex 04, 69317, France

Melissa GRUNER0426732888 Melissa.gruner@chu-lyon.fr

Centre Hospitalier Universitaire De Saint Etienne

Saint Priest En Jarez, 42270, France

Jean-Marc PHELIP0477828934

Central Study Contacts

Coordinator

0549443751 david.tougeron@chu-poitiers.fr

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

June 23, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-519258-35-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:59:27 UTC

Documents

D1_PROTOCOLE DOMZIGAST 2024-519258-35-00_redacted

You may not qualify if:

Concurrent enrolment in another clinical study – unless it is an observational study or during the follow-up period of an interventional study
Treatment with sorivudine and others analogues as brivudine (irreversibly inhibits the enzyme dihydropyrimidine dehydrogenase) within 4 weeks prior the first dose of treatment
Strong inducers of CYP3A4 and/or UGT1A1 and strong inhibitor of CYP3A4 within 7 days prior the first dose of treatment or known Gilbert disease: Strong inducers of CYP3A4 (treatment with St John’s Wort (Hypericum perforatum), fampicin, phenobarbital, primidone, phenytoin and carbamazepine (Appendix 12). Strong inhibitors of CYP3A4, continuous use of azole antifungals (posaconazole, voriconazole, itraconazole, isavuconazole), ritonavir, verapamil, diltiazem, grapefruit juice (equivalent to half a fresh grapefruit/day) (Appendix 12).
History of chronic inflammatory bowel disease (IBD) or intestinal obstruction
Any unresolved significant toxicity NCI CTCAE v5.0 ≥ grade 2 from previous anticancer therapy (excepted neuropathy and alopecia)
History of trauma or major surgery within 28 days prior to randomization (placement of central venous access catheter is not considered a major surgical procedure)
Active or prior documented serious autoimmune or inflammatory disorders that required systemic treatment in the past 2 years (e.g., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy or inflammatory disorders. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment as listed above
Active viral, bacterial or fungal infections requiring parenteral treatment within 14 days of randomization. Prophylactic antibiotic treatment (e.g., to prevent a urinary tract infection) is allowed
Vaccinations with live vaccine within 28 days prior to the start of treatment
History of idiopathic pulmonary fibrosis, interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on screening chest CT-scan)
Active hepatitis B or C and active tuberculosis (in case of if positive viral load is detected)
Prior treatment by immune checkpoint inhibitor
Known immunodeficiency or HIV infection with HIV viral load ≥200 copies/mL or CD4+ T-cell count <350 cells/μL or taking medications that may interfere with metabolism of study drugs
Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs (excepted: intranasal, inhaled, topical steroids or local steroid injection –at physiological dose that does not exceed 10 mg/day of prednisone or its equivalent – steroids as premedication for hypersensitivity reactions)
Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
+14 more criteria

PRODIGE 111 – DOMZIGAST A randomized phase II study evaluating FOLFIRI vs FOLFIRI plus Domvanalimab (anti-TIGIT) and Zimberelimab (anti-PD1) in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma with progression during or after peri-operative chemotherapy.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (29)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations