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Gastric AdenocarcinomaPhase 2LOGICANNCT05476796

Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer

A Phase 2 study testing Trifluridine/Tipiracil, Oxaliplatin and FOLFOX regimen in people with Gastric Adenocarcinoma and Esophagus Adenocarcinoma, run by UNICANCER at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trifluridine/Tipiracil, Oxaliplatin and FOLFOX regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
28 sitesFrance
Study dates
23 Jun 2023to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ) ineligible to curative treatment.
  • No dysphagia or difficulty in swallowing.
  • No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative). Known combined positive scor (CPS) PD-L1 score (result in % with the name of the method used). The microsatellite and mismatch repair (MMR) status of patient's tumour (MSI/MSS and pMMR/dMMR) must also be known at the time of screening (IHC and PCR tests have to be done).
  • At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area.
  • No prior palliative chemotherapy.
  • Age ≥18 years old.
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  • Patient eligible for FOLFOX chemotherapy
  • Adequate organs function:
  • Absolute neutrophils count ≥1.5x10⁹/L
  • Platelets count ≥100x10⁹/L
  • Haemoglobin ≥9 g/L
  • Serum bilirubin levels <2 times upper limit of normal (ULN), up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed)
  • Transaminases <5 times ULN
  • Creatinine clearance >40 mL/min
  • No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia <16 ng/ml)
  • Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before the first study treatment.
  • Patients must agree to use adequate contraception methods for the duration of study treatment and within 6 months after completing treatment.
  • Patients must be affiliated to a Social Security System (or equivalent).
  • Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.
  • Availability of archived tumour material for ancillary studies

Who cannot join

  • Patient with a performance status ECOG PS >2.
  • Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin treated by surgery).
  • Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months.
  • Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline.
  • Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients.
  • Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
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  • Previous treatment with trifluridine/tipiracil.
  • Known Human Immunodeficiency Virus (HIV) infection.
  • Active Hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen [HBsAg] test prior to inclusion) or hepatitis C virus (HCV).
  • Interstitial lung disease.
  • Prior pneumonitis requiring systemic corticosteroid therapy.
  • Active infections.
  • Pregnant or breastfeeding woman.
  • Participation in another therapeutic trial within the 30 days prior to randomisation.
  • Persons deprived of their liberty or under protective custody or guardianship.
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
  • Active systemic autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • Clinique de l'Europe

    Amiens, 80000

  • Hopital Privé Arras Les Bonnettes

    Arras, 62000

  • Institut Sainte Catherine

    Avignon, 84000

  • Centre Hospitalier de Beauvais

    Beauvais, 60021

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CHU Morvan

    Brest, 29200

  • Clinique Pasteur Lanroze

    Brest, 29200

  • CH Cholet

    Cholet, 49000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • CHU d'Estaing

    Clermont-Ferrand, 63100

  • Institut Andrée Dutreix - Clinique de Flandre

    Coudekerque-Branche, 59210

  • Hôpital Nord-Ouest Villefranche-sur-Saône

    Gleizé, 69400

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital Saint Joseph

    Marseille, 13008

  • Institut Paoli Calmettes

    Marseille, 13009

  • Hôpital Nord Franche Comté

    Montbéliard, 25250

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Saint Louis

    Paris, 75010

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • GH Diaconesses - Crois St Simon

    Paris, 75020

  • Institut Mutualiste Montsouris

    Paris, 75674

  • CHU de Poitiers

    Poitiers, 86000

  • CHU - Hôpital Robert Debré

    Reims, 51092

  • Institut Jean Godinot

    Reims, 51100

  • CHU Rouen - Charles Nicolle

    Rouen, 76000

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67033

  • CHU Nancy - Hôpital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin ± Nivolumab Versus FOLFOX ± Nivolumab in Patients With HER2 Negative Locally Advanced, Recurrent or Metastatic Gastric, Oesophageal or Oesogastric Junction Adenocarcinoma

Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.

Read the detailed description

Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin ± Nivolumab Versus FOLFOX ± Nivolumab in Patients With HER2 Negative Locally Advanced, Recurrent or Metastatic Gastric, Oesophageal or Oesogastric Junction Adenocarcinoma

Being tested
Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Keywords
Metastatic, Recurrent, Locally advanced, Trifluridine/Tipiracil, Gastrointestinal, Adenocarcinoma, FOLFOX, Oxaliplatin, Gastric Adenocarcinoma, Esophagus Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastric, Esophagus, Gastroesophageal Junction
Medical subject headings
Adenocarcinoma Of Esophagus, Neoplasm Metastasis, Recurrence, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trifluridine/TipiracilDrug

    Also called Lonsurf

    Trifluridine/Tipiracil will be administered with a 14-day schedule (35 mg/m² BID for 5 days followed by 9 days of recovery) until disease progression or intolerable toxicity.

  • OxaliplatinDrug

    Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity.

  • FOLFOX regimenDrug

    Folinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity.

  • NivolumabDrug

    Also called OPDIVO

    Nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years

Study groups in NCT05476796
Study groupRoleWhat they receive
Trifluridine/Tipiracil + Oxaliplatin ± nivolumabExperimentalTrifluridine/Tipiracil will be administered with a 14-day schedule (35 mg/m² twice-daily [BID] for 5 days followed by 9 days of recovery) until disease progression or intolerable toxicity. Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity. ± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years.
Receives: Drug: Trifluridine/Tipiracil; Drug: Oxaliplatin; Drug: Nivolumab
FOLFOX ± nivolumabActive comparatorFolinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity. ± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years.
Receives: Drug: FOLFOX regimen; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free-survival

    The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: From randomization to disease progression or death up to 5 years

Secondary outcomes (5)

  1. Objective response rate

    Objective response rate (ORR) is defined as the percentage of patients with a best response during treatment being either Complete Response (CR) or Partial Response (PR).

    Measured: 5 years

  2. Overall survival

    The overall survival (OS) is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From randomization to death from any cause, up to 5 years

  3. Incidence of Treatment Adverse Events

    The tolerance and safety will be evaluated by toxicity (acute [<1 months after the end of the trial treatment] and late [≥1 month after the end of the trial treatment), assessed using the Common terminology criteria for adverse events version 5.0 (CTCAE v5.0). CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 5 years

  4. Time to patient performance status deterioration >2

    Time to performance status (PS) deterioration >2 is defined as the time between patient randomisation and the first date when PS>2.

    The Eastern Cooperative Oncology Group (ECOG) PS, a simple measure of functional status, determines ability of patient to tolerate therapies. It has scores ranging from 0 to 5 (0 = "fully active", 1 = "completely ambulatory", 2 = "<50% in bed during the day", 3 = ">50% in bed, but not bedbound", 4 = "bedbound", and 5 = "death").

    Measured: From randomization to PS deterioration >2, up to 5 years

  5. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: From baseline until disease progression, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start23 Jun 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05476796
Sponsor's protocol ID
UC-GIG-2203
Other IDs
2022-000273-81, 2024-512999-35-00
Acronym
LOGICAN
Status last verified
Jul 2026
First submitted
26 Jul 2022
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Publications

  • Botsen D, Chabaud S, Perrier H, Ammarguellat H, Jestin-Le-Tallec V, Olesinski J, Toullec C, Aparicio T, Ben Abdelghani M, Borg C, Bouche O, Coutzac C, Devaud H, Di Fiore F, Dubreuil O, Evesque L, Huguenin B, Muller M, Poureau PG, Oularue E, Tougeron D, Zaanan A, Ammari S, De Sousa Carvalho N, Decazes P, De La Fouchardiere C. Trifluridine/tipiracil + oxaliplatin +/- nivolumab vs FOLFOX +/- nivolumab in HER2 negative advanced oesogastric adenocarcinoma: The PRODIGE73-UCGI40-LOGICAN trial. Dig Liver Dis. 2024 Aug;56(8):1281-1287. doi: 10.1016/j.dld.2024.04.032. Epub 2024 May 17.

    PubMed 38762353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trifluridine/Tipiracil, Oxaliplatin and FOLFOX regimen in people with Gastric Adenocarcinoma and Esophagus Adenocarcinoma, run by UNICANCER at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free-survival (time frame: From randomization to disease progression or death up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05476796, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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