Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer

Objective response rate

Objective response rate is defined as the percentage of patients achieving complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 for CRC and modified RECIST criteria for CRLM.

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.

Pathological complete response

The pathological complete response is defined as the absence of invasive neoplastic cells upon microscopic examination of the tumor during surgery.

The rate of conversion to resectable status

Assessment of resectability represents a complex biological and technical decision; definitions of resectability vary substantially and are contingent on technical expertise, institutional surgical volume, institutional experience, and access to multidisciplinary oncological care. For the present clinical trial, the following resectability criteria will be applied: (i) Following 4 cycles of conversion therapy, simultaneous or staged complete surgical resection of the primary tumor and liver metastases can be performed. (ii) The primary lesion can be resected en bloc with R0 margins. (iii) Liver metastases can be treated with radical ablation alone or combined with radical surgical resection to achieve R0 margins; the future liver remnant constitutes no less than 30%-40% of the total liver volume. (iv) Patients maintain acceptable general status and have no additional distant metastases precluding local radical treatment. (v) Regional lymph node metastases are amenable to complete surg

Adverse events

Adverse events (AEs) include chemotherapy-related and catheter-related complications, which will be graded in accordance with the National Cancer Institute Common Terminology Criteria for AEs, version 6.0.