About this trial
This is a prospective, multicenter, randomized, and open-label clinical trial. It is initiated to determine the efficacy of FOLFOX-based, transarterial infusion chemotherapy (TAIC) combined with either cetuximab or bevacizumab for patients with unresectable colorectal cancer (CRC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Colorectal cancer confirmed by CT/MRI and colonoscopic biopsy;
Patients unfit for surgery due to poor general condition or tumor extent and location;
Patients who have not received prior chemotherapy or those who have undergone prior chemotherapy but remain chemosensitive.
Disqualifiers
Patients with other primary malignant tumors;
Patients with gastrointestinal perforation;
Patients are allergic to the antitumor agents;
Women who are pregnant, breastfeeding, or planning to become pregnant;
Trial design
Parallel
Treatments tested in this trial
Transarterial infusion chemotherapy (TAIC)
Procedure/SurgeryTAIC can increase the local intra-tumoral concentrations of chemotherapeutic agents by intensifying drug delivery into the tumor via super-selective catheterization of the tumor-feeding artery, and meanwhile reduce systematic toxicity.
Intravenous Chemotherapy(IVC)
Procedure/SurgeryIntravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.
Treatment groups
Trial outcomes
Primary outcomes
ORR
ORR is defined as the percentage of complete response and partial response that is maintained for at least 4 weeks from the first radiological confirmation.
Secondary outcomes
Health-related quality of life
Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer (EORTC) 30-item QoL Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items covering five functioning scales (physical, social, emotional, role, and cognitive), nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, diarrhea, and financial impact), and a global health status scale. Referring to a recall period of one-week (except for physical function, which does not refer to a recall period at all), patients indicate their answers on a 4-point Likert scale. Linear converted scale scores range from 0 to 100. Higher scores on the functioning scales and on the global health status scale indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
Clinical complete response
Clinical complete response is defined as no visible tumor on imaging examination.
The rate of conversion to resectable status
The assessment of surgical resectability by an experienced and dedicated multidisciplinary team is required at each tumor assessment.
Pathological complete response
The pathological complete response is defined as the absence of invasive neoplastic cells upon microscopic examination of the primary tumor during surgery.
Other outcomes
Adverse events
Adverse events are defined that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0.
Locations
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Sponsors and contacts
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Quanda Liu
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor institution
Liaoning Cancer Hospital & Institute
Collaborator
The Rocket Force Characteristic Medical Center
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Affiliated Hospital of Hebei University
Collaborator
The First Hospital of Qinhuangdao
Collaborator
The Central Hospital of Handan City
Collaborator
The First People's Hospital of Jiujiang City
Collaborator
Changzhi Medical College
Collaborator
Zibo Boshan District Traditional Chinese Medicine Hospital
Collaborator
Linshu County People's Hospital
Collaborator
Hebei Yixian Hospital
Collaborator
Baoding Mancheng District People's Hospital
Collaborator