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OncoMatch/Clinical Trials/NCT05988814

Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy

Is NCT05988814 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies FOLFIRINOX treatment for metastatic pancreatic cancer.

Phase 2RecruitingCentre Georges Francois LeclercNCT05988814Data as of May 2026

Treatment: FOLFIRINOX treatmentEvaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Excluded: DPYD homozygous or heterozygous mutation

Excluded: UGT1A1 homozygous genotype

Disease stage

Required: Stage III, IV

Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer; at least one measurable lesion according to RECIST 1.1 criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Exception: prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months

Patients with no history of chemotherapy (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months)

Cannot have received: curative radiotherapy

no history of curative radiotherapy for metastatic or locally advanced disease

Lab requirements

Blood counts

Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)

Kidney function

Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)

Liver function

Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)

Cardiac function

No active heart disease; An ECG with a QT/QTc interval < 450 ms for men and < 470 ms for women; No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management

Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and folinic acid) including but not limited to: No active heart disease An ECG with a QT/QTc interval < to 450 ms for men and < to 470 ms for women. No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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