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Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer

NCT05420584 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasms

Interventions

PROCEDURE

Arterial chemoembolization

The blood supplying artery of the tumor is selected for drug injection with Oxaliplatin 85mg/m2 combined Raltitrexed 3mg/m2. After drug injection, gelatin sponge is used for embolization.

DRUG

Tislelizumab Injection

Tislelizumab Injection 200mg i.v. q3w, A total of 3 cycles are administered.

DRUG

XELOX

Capecitabine 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, i.v. day 1 Cycles are repeated on day 22. A total of 3 cycles are administered.

DIAGNOSTIC_TEST

Pelvic MRI

Pelvic MRI to evaluate efficacy

PROCEDURE

Laparoscopic radical resection of rectal cancer

Surgical treatment for patients who meet the surgical conditions

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2024-11-30
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420584 on ClinicalTrials.gov