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Rechallenge therapy shows promise for Tough-to-Treat colorectal cancer

NCT ID NCT07381764

Disease control Sponsor: Gruppo Oncologico Italia Meridionale Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This phase 2 trial compares a rechallenge treatment (irinotecan plus cetuximab) against the current standard (trifluridine/tipiracil plus bevacizumab) for people with metastatic colorectal cancer whose disease has worsened after earlier therapies. Only patients with specific genetic markers, identified through a blood test, are eligible. The goal is to see if the rechallenge leads to more tumor shrinkage and better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
irinotecan plus cetuximab
What this could lead to
If successful, this rechallenge approach could offer a more effective third-line treatment option for certain patients with metastatic colorectal cancer.
What could go wrong
This is a phase 2 trial with only 150 participants, so results may not apply broadly. The rechallenge strategy may not work for everyone and could cause side effects like infusion reactions or severe diarrhea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged ≥18 years 2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1 3. Diagnosis of histologically or cytologically confirmed colorectal cancer. 4. At least one measurable lesion according to RECIST1.1 5. KRAS/NRAS/BRAFV600E wt status of primary CRC or related metastasis (local laboratory assessment). 6. Progression to previous first-line anti-EGFR-containing therapy producing at least a partial response ≥ 6 months. 7. Received and progressed to an anti-EGFR and irinotecan free second-line treatment. 8. Have an anti-EGFR free interval of at least 4 months. 9. Refractory to previous 5-fluorouracil/capecitabine, irinotecan, oxaliplatin, bevacizumab. 10. RAS/BRAF/EGFR/PIK3CAex20/MAP2K1/MET WT and HER2 not amplified ctDNA at FoundationOne CDx test at baseline. 11. Life expectancy of at least 3 months. 12. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused). 13. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). 14. Adequate renal function defined by an estimated creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). 15. No contraindication to the study drugs. 16. No prior treatment with trifluridine/tipiracil. 17. Women of childbearing potential\* must have a negative blood pregnancy test at thescreening visit. Subjects and their partners must be willing to avoid pregnancy during the trial. \*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. 18. Women of childbearing potential, or male, must agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate. 19. Will and ability to comply with the protocol. 20. Signed informed consent obtained before screening. Exclusion Criteria: 1. ECOG PS ≥2 2. Received more than 2 lines of treatment for metastatic disease. 3. Previous treatment with trifluridine/tipiracil 4. RAS/BRAF/EGFR/PIK3CAex20/MAP2K1/MET WT HER2 not amplified status at liquid biopsy analysis during screening. 5. Previous history of malignancy within the last 2 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ 6. Evidence of bleeding diathesis or coagulopathy. 7. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy. 8. Known severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma). 9. Clinically significant cardiovascular disease, active inflammatory bowel disease, active autoimmune disease. 10. Diagnosis of interstitial pneumonitis or pulmonary fibrosis. 11. History of abdominal fistula, GI perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment. 12. Pregnant or lactating women. 13. Psychiatric or addictive disorders would preclude study participation. 14. Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study treatments. 15. Withdrawal of the consent to take part to the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer (CRC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. 'Pia Fondazione Cardinale G. Panico'

    NOT_YET_RECRUITING

    Tricase, Italy

  • A.O.R.N. "Sant'anna e San Sebastiano"

    RECRUITING

    Caserta, Italy

  • A.O.U. Careggi

    RECRUITING

    Florence, Italy

  • A.O.U. Ospedali Riuniti

    RECRUITING

    Ancona, Italy

  • A.O.U. Pisana

    RECRUITING

    Pisa, Italy

  • A.O.U. Sassari

    RECRUITING

    Sassari, Italy

  • A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"

    RECRUITING

    Naples, Italy

  • A.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima

    NOT_YET_RECRUITING

    Catania, Italy

  • AOU Policlinico di Modena

    RECRUITING

    Modena, Italy

  • ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'

    NOT_YET_RECRUITING

    Palermo, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • ASST Sette Laghi-Ospedale di Circolo Fondazione Macchi

    RECRUITING

    Varese, Italy

  • Azienda Ospedaliero Universitaria "SS Antonio e Biagio e Cesare Arrigo"

    RECRUITING

    Alessandria, Italy

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    NOT_YET_RECRUITING

    Catanzaro, Italy

  • Casa di Cura Villa Maria

    RECRUITING

    Mirabella Eclano, Italy

  • Casa di cura Macchiarella

    NOT_YET_RECRUITING

    Palermo, Italy

  • Centro di Riferimento Oncologico (CRO), IRCCS

    RECRUITING

    Aviano, Italy

  • Fondazione IRCCS Istituto Nazionale Tumori

    RECRUITING

    Milan, Italy

  • Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza

    NOT_YET_RECRUITING

    San Giovanni Rotondo, Italy

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    RECRUITING

    Roma, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, Italy

  • Istituto Nazionale Tumori 'Fondazione G. Pascale'

    RECRUITING

    Naples, Italy

  • Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, Italy

  • Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'

    RECRUITING

    Meldola, Italy

  • Ospedale IRCCS 'Saverio de Bellis'

    NOT_YET_RECRUITING

    Castellana Grotte, Italy

  • Ospedale San Giuseppe Moscati

    RECRUITING

    Statte, Italy

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