Phase Ⅱ Clinical Trial of Neoadjuvant Arterial Embolization Chemotherapy Combined Immune Checkpoint Inhibitor for Locally Advanced Rectal Cancer: A Single Arm Prospective Sturdy

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Rectal cancer is one of the common malignant tumors of the digestive tract. Some patients with rectal cancer are already advanced tumors when they are first diagnosed. At this time, the tumor has local infiltration, the probability of recurrence and metastasis after surgical resection is high, and even radical tumor resection cannot be performed. Neoadjuvant chemotherapy and radiotherapy have become one of the important treatment methods for these patients to increase the rate of radical tumor resection. However, a series of side effects of neoadjuvant radiotherapy can even continue after the end of radiotherapy, and even increase the incidence of postoperative complications. Superselective arterial interventional chemotherapy has been widely used in preoperative neoadjuvant chemotherapy for various tumors, and its efficacy in rectal cancer has also been confirmed. In addition, as a hot spot in tumor treatment, tumor immunotherapy has shown exciting effects in the NICHE study of neoadjuvant immunotherapy before colon cancer surgery. Moreover, Oxaliplatin is a classic chemotherapeutic drug that induces Immunogenic cell death effects, which induce antitumor immunity. Therefore, in order to optimize the preoperative neoadjuvant therapy plan, the investigators propose a treatment method of superselective arterial chemoembolization combined with immunotherapy and systemic chemotherapy, in order to obtain better preoperative conversion therapy effect and reduce the adverse reactions of neoadjuvant therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Pathologically confirmed rectal adenocarcinoma (immunohistochemistry, polymerase chain reaction(PCR) or next-generation sequencing(NGS) sequencing methods are acceptable).

• Magnetic resonance imaging (MRI) measurement of tumor inferior margin ≤12cm from the anus.

• MRI staging is cT3-4 N0 or cT1-4 N+, no multiple primary cancers or distant metastasis.

• Life expectancy ≥ 1 year.

• No anti-tumor therapy, no contraindications to interventional embolization, immunotherapy and chemotherapy.

• Patients who understand the study protocol and are willing to participate in this study provide written informed consent.

Locations
Other Locations
China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Yiwu
Time Frame
Start Date: 2022-11-29
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 83
Treatments
Experimental: experimental arm
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov

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