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Testing a new chemotherapy for patients with DPD deficiency and metastatic cancer

TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial

Phase 2 Interventional Unicancer · NCT06245356

This study is testing a new chemotherapy drug for people with DPD deficiency and advanced colorectal or gastroesophageal cancer to see if it is safer and more effective than standard treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment73 (estimated)
Ages18 Years and up
SexAll
SponsorUnicancer Academic / other
Drugs / interventionsbevacizumab, trastuzumab, panitumumab, Nivolumab, chemotherapy
Locations21 sites (Amiens and 20 other locations)
Trial IDNCT06245356 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety of trifluridine/tipiracil as an alternative to traditional fluoropyrimidine-based chemotherapy in patients with dihydropyrimidine dehydrogenase (DPD) deficiency who have metastatic colorectal or gastroesophageal cancer. Participants will receive trifluridine/tipiracil combined with oxaliplatin and either panitumumab or bevacizumab for colorectal cancer, or nivolumab or trastuzumab for gastroesophageal cancer. The study will assess safety, progression-free survival, overall survival, objective response rate, disease control rate, and quality of life. CT scans will be conducted every two months to monitor disease progression.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic colorectal or gastroesophageal adenocarcinoma who have documented DPD deficiency and no prior therapy for metastatic disease.

Not a fit: Patients without DPD deficiency or those who have received prior therapy for metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer chemotherapy option for patients with DPD deficiency and metastatic cancer.

How similar studies have performed: While this approach is novel for patients with DPD deficiency, similar studies have shown promise in evaluating alternative chemotherapy regimens for metastatic cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)
3. Synchronous or metachronous metastatic colorectal or gastroesophageal cancer
4. Presence of at least one measurable lesion according to RECIST v1.1
5. No prior therapy for metastatic disease
6. known DPD deficiency defined as plasma uracil concentration≥16 ng/ml For plasma uracil concentration \[16-20\[ ng/ml, plasma uracil dosage must be repeated in the 7 days to confirm that plasma uracil concentration ≥16 ng/ml. If the second result is different (i.e; uracil concentration \<16 ng/ml), keep the favourable result, and do not include the patient if only the first plasma uracil concentration≥16 ng/ml.
7. Age ≥18 years
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
9. Adequate bone marrow, renal and liver functions as evidenced by the following laboratory requirements within 7 days prior to study treatment initiation:

   1. Absolute neutrophil count (ANC) ≥ 1,500/ mm³ without biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF), within 21 days before the start of study treatment
   2. Platelet count ≥100,000/mm³, without platelet transfusion within 21 days before the start of study treatment
   3. Hemoglobin (Hb) ≥9 g/dL, without blood transfusion or erythropoietin within 21 days before the start of study treatment
   4. Serum creatinine ≤1.5 x upper limit of normal (ULN)
   5. Glomerular filtration rate as assessed by the estimated glomerular filtration rate (eGFR) ≥50 mL/min per 1.73 m² calculated by the Modification of Diet in Renal Disease (MDRD) abbreviated formula
   6. Total bilirubin ≤ 1.5 x ULN
   7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)
   8. Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement for their cancer and/or bone metastases)
   9. International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 x ULN Note: Patients on stable dose (dose has not been changed in at least 28 days) of anticoagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator's discretion. In such case, limits as noted would not apply
10. For women of reproductive potential, negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days before the start of study treatment. Women not of reproductive potential are female patients who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy)
11. For women of childbearing potential and men, agreement to use an adequate contraception for the duration of study participation and up to 7 months following completion of therapy.
12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
13. Affiliation to the Social Security System (or equivalent).

Exclusion Criteria:

1. Previous or concurrent cancer that is distinct in primary site or histology from colorectal or gastroesophageal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\]
2. Radiotherapy within 28 days prior to first dose of treatment
3. Active cardiac disease including any of the following:

   1. Symptomatic Congestive heart failure ≥New York Heart Association (NYHA) class 3 or 4
   2. Severe Unstable angina (angina symptoms at rest)
   3. Myocardial infarction less than 12 months before first dose of treatment
4. Uncontrolled hypertension (Systolic blood pressure ≥140 mmHg or diastolic pressure ≥ 90 mmHg) despite optimal medical management.
5. Ongoing infection ≥Grade 2 (NCI CTCAE v.5.0)
6. Known history of human immunodeficiency virus (HIV) infection
7. Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)
8. Seizure disorder requiring medication
9. Symptomatic metastatic brain or meningeal tumours
10. History of organ allograft
11. Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products
12. In case of planned treatment with oxaliplatin: Peripheral neuropathy \>Grade 1 (NCI CTCAE v.5.0)
13. In case of planned treatment with bevacizumab: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose of treatment
14. In case of planned treatment with bevacizumab: Evidence or history of any bleeding diathesis, irrespective of severity. Any hemorrhage or bleeding event ≥CTCAE v 5.0 Grade 3 within 4 weeks prior to the start of study medication
15. In case of planned treatment with trastuzumab or panitumumab or bevacizumab: Interstitial lung disease with ongoing signs and symptoms
16. Inability to swallow oral medication
17. Any uncontrolled malabsorption condition
18. Pregnant or breast-feeding subjects. Women of childbearing potential must have a serum pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug
19. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, substance abuse, medical or psychological reasons, or any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study or evaluation of study treatment or interpretation of patient safety or study results
20. Participation in another clinical study with an investigational product during the last 30 days before inclusion
21. Patients who might be interconnected with or dependent on the sponsor site or the investigator
22. Persons deprived of their liberty or under protective custody or guardianship, or legal incapacity or limited legal capacity

Where this trial is running

Amiens and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerMetastatic Gastroesophageal AdenocarcinomaDPD DeficiencyMetastatic colorectal cancerTrifluridine/Tipiracil
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.