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

ConditionColorectal Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • irinotecan liposome (II)

    Drug

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

  • fluorouracil

    Drug

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

  • cetuximab

    Drug

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

  • bevacizumab

    Drug

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

  • Capecitabine

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: irinotecan liposome (II), fluorouracil in combination with bevacizumabExperimental treatment 4 interventions
Group B: irinotecan liposome (II), fluorouracil in combination with cetuximabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

Objective Response Rate

Time frame
through study completion, an average of 1 year.

Secondary outcomes

1

Progression-free survival

Progression-Free-Survival

Time frame
median progression-Free-Survival approximately 4-7 months
2

Overall survival

Overall survival

Time frame
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

Time frame
through study completion, assessed up to 50 months
4

Qol

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

Time frame
through study completion, assessed up to 50 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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