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Colorectal Cancer MetastaticPhase 2NCT06547203

Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

A Phase 2 study testing Cetuximab, Toripalimab and Irinotecan in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Cetuximab, Toripalimab and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
18 Jul 2024to 30 Jul 2029
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed colorectal adenocarcinoma.
  • Primary tumor located in the right colon.
  • Metastatic disease with at least one measurable lesion according to RECIST v1.1 criteria.
  • Histologically tested as RAS/BRAF V600E wild-type and negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.
  • Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil, with tumor progression occurring during or within 3 months after irinotecan treatment.
  • No prior treatment with anti-EGFR or PD-1 antibodies.
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  • Normal hematological function (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L).
  • Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN.
  • No ascites, normal coagulation function, albumin ≥35 g/L.
  • Liver function classified as Child-Pugh grade A.
  • Serum creatinine less than ULN, or calculated creatinine clearance >50 ml/min (using the Cockcroft-Gault formula).
  • At least one measurable lesion according to RECIST v1.1 criteria.
  • ECOG performance status of 0-2.
  • Expected survival >3 months.
  • Signed written informed consent.
  • Willing and able to undergo follow-up until death or study completion or termination.

Who cannot join

  • Severe arterial thrombosis or ascites.
  • Bleeding tendencies or coagulation disorders.
  • Hypertensive crisis or hypertensive encephalopathy.
  • Severe uncontrolled systemic complications such as infections or diabetes.
  • Clinically significant cardiovascular diseases such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medication, unstable angina, congestive heart failure (NYHA grade 2-4), or arrhythmias requiring medication.
  • History of or physical examination showing central nervous system diseases (e.g., primary brain tumor, uncontrolled epilepsy, any history of brain metastasis or stroke).
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  • Other malignancies within the past 5 years (except for basal cell carcinoma of the skin after curative surgery and/or carcinoma in situ of the cervix).
  • Use of immunosuppressive drugs within 1 week before treatment, excluding nasal, inhaled, or other topical steroids or physiological doses of systemic steroids (i.e., not exceeding 10 mg/day of prednisone or an equivalent dose of other steroids) or steroids used to prevent contrast agent allergies.
  • Steroid-dependent interstitial lung disease.
  • Known active autoimmune disease requiring symptomatic treatment or history of such disease within the past 2 years. Patients with vitiligo, psoriasis, alopecia, or -Graves' disease not requiring systemic treatment within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type I diabetes requiring only insulin replacement can be enrolled.
  • Known history of primary immunodeficiency.
  • Known active tuberculosis.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Receipt of any investigational drug treatment within the last 28 days before the study.
  • Allergy to any drugs in the study.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential (within 2 years of last menstruation) or men capable of fathering a child who are not using or refuse to use effective non-hormonal contraceptive methods (e.g., intrauterine device, barrier method combined with spermicide, or sterilization).
  • Inability or unwillingness to comply with the study protocol.
  • Presence of any other disease, functional impairment caused by metastatic lesions, or suspicious conditions found during a physical examination indicating a contraindication to the study drugs or high risk for treatment-related complications.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuhong Li, PhD contact

87342487 ext. 020

liyh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Yuhong, MD, 020-87342487, liyh@sysucc.org.cn

    Li Yuhong, MD

    Recruiting

Other trials in China

About this study

Official title: Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study

The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.

Read the detailed description

The present study focuses on exploring the effectiveness and safety of cetuximab combined with a PD-1 inhibitor and irinotecan in treating refractory, right-sided metastatic colorectal cancer (mCRC) patients who are negative ultraselected for RAS/BRAF mutations. Colorectal cancer ranks among the most prevalent digestive malignancies globally, with right-sided mCRC generally exhibiting poorer outcomes than left-sided cases. Current treatment guidelines vary based on genetic mutations and tumor location, recommending cetuximab for left-sided RAS/BRAF wild-type mCRC and alternative therapies for right-sided or mutated cases. Despite limited clinical data on EGFR inhibitors for right-sided mCRC, retrospective analyses suggest varying efficacy outcomes. The study aims to address these gaps by investigating cetuximab and PD-1 inhibitor combination therapy in this specific patient population, potentially enhancing treatment options for refractory mCRC.

Keywords
Metastatic colorectal cancer, RAS/BRAF wild type, Right-sided, Cetuximab, PD-1 inhibitor
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • CetuximabDrug

    Also called Erbitux

    Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks

  • ToripalimabDrug

    Also called Loqtorzi

    Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks.

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks.

Study groups in NCT06547203
Study groupRoleWhat they receive
Cetuimab plus toripalimab and irinotecanExperimentalSingle Arm study, with patients receiving: Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks. Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks. Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks. Patients will continue treatment until any of the following conditions occur: the researcher determines there is no longer a clinical benefit, intolerable toxicity occurs, a new anti-tumor treatment is initiated, withdrawal of informed consent, loss to follow-up, death, or other conditions specified in the protocol requiring termination of treatment.
Receives: Drug: Cetuximab; Drug: Toripalimab; Drug: Irinotecan

What is being measured

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

  1. Objective Response Rate

    The proportion of patients who have achieved partial response (PR) plus complete response (CR), as assessed by the investigator using RECIST v1.1 criteria

    Measured: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months

Secondary outcomes (5)

  1. Disease Control Rate

    The proportion of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) following treatment initiation.

    Measured: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months

  2. Duration of Response

    Length of time from the initial detection of a measurable response (complete response or partial response) to the treatment until the first documentation of disease progression or recurrence

    Measured: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months

  3. Progression-Free Survival

    The length of time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.

    Measured: Assessed up to 24 months

  4. Overall Survival

    Defined as the time from the start of study treatment to death due to any cause

    Measured: Assessed throughout the study duration (5 years)

  5. Adverse events (Treatment-related)

    Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria.

    Measured: Assessed throughout the study duration (5 years)

Timeline

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

  1. First posted9 Aug 2024
  2. Study start18 Jul 2024
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Jul 2029 (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
Not applicable
Intervention model
Single group
Model description
To investigate the objective response rate (ORR) of cetuximab combined with toripalimab and irinotecan in right-sided mCRC patients with negative ultraselected RAS/BRAF wild-type who have progressed after previous treatments with bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547203
Sponsor's protocol ID
CITRUS
Status last verified
Aug 2024
First submitted
18 Jul 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Toripalimab and Irinotecan in people with Colorectal Cancer Metastatic, run by Sun Yat-sen University at 1 site in China.

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 16 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Contact Yuhong Li, PhD (87342487 ext. 020, liyh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months). 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 NCT06547203.

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 9 Aug 2024.

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