Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuanda Liu

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Transarterial infusion chemotherapy (TAIC)

    Procedure/Surgery

    TAIC 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/Surgery

    Intravenous administration of chemotherapeutic agents is the mainstay of chemotherapy.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: TAIC GroupExperimental treatment 1 intervention
Group B: IVC groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

Clinical complete response

Clinical complete response is defined as no visible tumor on imaging examination.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

1

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.

Time frame
8 weeks

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting100053, Xicheng, Beijing MunicipalityChinaChina

Sponsors and contacts

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

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