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Colorectal Cancer MetastaticPhase 2NCT06540326

Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab

A Phase 2 study testing irinotecan liposome (II), fluorouracil and cetuximab in people with Colorectal Cancer Metastatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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
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Trial summary

Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
irinotecan liposome (II), fluorouracil and cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
12 Nov 2024to 31 Oct 2027
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent to voluntarily enroll in this study.
  • Men or women aged 18-75 years.
  • Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
  • Patients who have failed one prior systemic therapy.
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
  • Life expectancy of at least 3 months.
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  • Measurable lesions at baseline as assessed by the investigator by imaging (according to RECIST 1.1), measurable lesions should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred).
  • Function of vital organs in accordance with the following requirements (no medication with any blood component, cell growth factor corrective therapy is allowed within 14 days prior to the first administration of study drug); Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L; Haemoglobin ≥ 9 g/dL; Serum albumin ≥ 2.5 g/dL; Total bilirubin ≤ 1.5 × upper limit of normal; alanine aminotransferase, aspartate aminotransferase≤ 2.5 × upper limit of normal, and if liver metastases are present, alanine aminotransferase, aspartate aminotransferase ≤ 5 × upper limit of normal Serum creatinine ≤ 1.5 × upper limit of normal or creatinine clearance > 60 mL/min (Cockcroft-Gault); Activated partial thromboplastin time (APTT) and International Normalised Ratio (INR) ≤ 1.5 × upper limit of normal (screened for use of stable doses of anticoagulant therapy such as low molecular heparin or warfarin where the INR is within the expected therapeutic range of the anticoagulant).
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiation of trial drug administration and use effective contraception (e.g., intrauterine device, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose of trial drug; for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for at least 3 months after the last dose of trial drug. For male subjects whose partners are women of childbearing potential

Who cannot join

  • Have received local radiotherapy within 4 weeks prior to the first dose of study drug and have not recovered to baseline levels of adverse events due to radiotherapy. Subjects who have had palliative radiotherapy to a peripheral site (e.g., bone metastases) prior to 4 weeks may be admitted to the study, provided they have recovered from any acute adverse events;
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects previously treated for brain metastases may enter the study provided they have stable brain metastases and have not been treated for brain metastases with steroids for at least 28 days prior to study entry. This exception does not include carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability;
  • Major surgery, open biopsy, or severe trauma 28 days prior to first dose;
  • Have a previous history of hypersensitivity to fluorouracil or irinotecan;
  • Subjects with hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)
  • Subject has uncontrolled cardiovascular clinical symptoms or disease, including but not limited to: (1) New York Heart Association Class II or higher heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically interfered with or remains poorly controlled after clinical intervention.
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  • Clinically significant bleeding symptoms or a definite bleeding tendency within 3 months prior to the first dose, e.g., gastrointestinal bleeding, bleeding gastric ulcer, or vasculitis;
  • Arterial/venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accidents (including temporary ischaemic attack, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, with superficial venous thrombosis being eligible for enrolment as determined by the investigator;
  • Have another malignancy that is progressing or requires aggressive treatment, except for non-melanoma skin cancer and cervical cancer in situ for which potential treatment has been administered;
  • Women who are pregnant or breastfeeding;
  • Subjects who, in the judgement of the investigator, have other factors that may cause them to be forced to terminate the study midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, grossly abnormal laboratory test values, and family or social factors that may affect the subject's safety or the collection of trial data

Trial locations and contacts

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

China1 site, 1 recruiting

  • The second affiliated hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Hanguang Hu, 057187784718, huhanguang@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Second-line Treatment of Patients With Advanced Colorectal Cancer With Irinotecan Liposome (II), Fluorouracil in Combination With Bevacizumab or Cetuximab

Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.

Read the detailed description

Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer. Liposomal irinotecan (II) compared with ordinary irinotecan can improve efficacy and safety. This study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.

Being tested
irinotecan liposome (II), fluorouracil, cetuximab, bevacizumab, Capecitabine

What participants receive

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

  • irinotecan liposome (II)Drug

    Also called irinotecan liposome (II) injection

    irinotecan liposome (II) is a powerful chemotherapeutic agents, in the combination with fluorouracil，and bevacizumab or cetuximab

  • fluorouracilDrug

    Also called 5-fluorouracil

    fluorouracil is a powerful chemotherapeutic agents, in the combination with irinotecan liposome (II)，and bevacizumab or cetuximab

  • cetuximabDrug

    Also called cetuximab injection

    cetuximab is a powerful targeted agents, in the combination with irinotecan liposome (II)，and fluorouracil

  • bevacizumabDrug

    Also called bevacizumab injection

    bevacizumab is a powerful targeted agents, in the combination with irinotecan liposome (II)，and fluorouracil

  • CapecitabineDrug

    Capecitabine is a powerful chemotherapeutic agent, in the combination with bevacizumab or cetuximab

Study groups in NCT06540326
Study groupRoleWhat they receive
irinotecan liposome (II), fluorouracil in combination with bevacizumabExperimentalExperimental: irinotecan liposome (II), fluorouracil in combination with bevacizumab Induction therapy: irinotecan liposome (II), fluorouracil in combination with bevacizumab Maintenance therapy: bevacizumab with irinotecan liposome (II) or Capecitabine
Receives: Drug: irinotecan liposome (II); Drug: fluorouracil; Drug: bevacizumab; Drug: Capecitabine
irinotecan liposome (II), fluorouracil in combination with cetuximabExperimentalExperimental: irinotecan liposome (II), fluorouracil in combination with cetuximab Induction therapy: irinotecan liposome (II), fluorouracil in combination with bevacizumab Maintenance therapy: cetuximab with irinotecan liposome (II) or Capecitabine
Receives: Drug: irinotecan liposome (II); Drug: fluorouracil; Drug: cetuximab; Drug: Capecitabine

What is being measured

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

  1. Objective Response Rate

    Objective Response Rate

    Measured: through study completion, an average of 1 year.

Secondary outcomes (4)

  1. Progression-free survival

    Progression-Free-Survival

    Measured: median progression-Free-Survival approximately 4-7 months

  2. Overall survival

    Overall survival

    Measured: median overall survival approximately 8-20 months

  3. Adverse Events

    All adverse medical events occurring after the subject has received the experimental All adverse medical events occurring after the subject has received the experimental intervention

    Measured: through study completion, assessed up to 50 months

  4. Qol

    Assessment of patients' quality of life by means of quality of life score questionnaires

    Measured: through study completion, assessed up to 50 months

Timeline

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

  1. First posted6 Aug 2024
  2. Study start12 Nov 2024
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completion31 Oct 2027 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540326
Sponsor's protocol ID
MA-CRC-II-012
Status last verified
Jul 2025
First submitted
22 Jul 2024
Last updated
22 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan liposome (II), fluorouracil and cetuximab in people with Colorectal Cancer Metastatic, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 11 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 22 Dec 2025. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: through study completion, an average of 1 year.). 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 NCT06540326.

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 22 Dec 2025.

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