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

May 9, 2023 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologically confirmed rectal adenocarcinoma (immunohistochemistry, polymerase chain reaction(PCR) or next-generation sequencing(NGS) sequencing methods are acceptable).
  2. Magnetic resonance imaging (MRI) measurement of tumor inferior margin ≤12cm from the anus.
  3. MRI staging is cT3-4 N0 or cT1-4 N+, no multiple primary cancers or distant metastasis.
  4. Life expectancy ≥ 1 year.
  5. No anti-tumor therapy, no contraindications to interventional embolization, immunotherapy and chemotherapy.
  6. Patients who understand the study protocol and are willing to participate in this study provide written informed consent.

Exclusion Criteria:

  1. Refuse to participate in this study.
  2. Multifocal colorectal cancer.
  3. Past history of malignancy, excluding basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ.
  4. Inability to receive chemotherapy, such as but not limited to bone marrow suppression, etc.
  5. Major organ diseases (such as but not limited to chronic obstructive pulmonary disease, coronary heart disease and renal insufficiency, etc.) during acute exacerbation and or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia and myocarditis, etc.), American Society of Anesthesiologists(ASA) score > 3.
  6. Mental disability or illiteracy or language and communication barriers cannot understand the research protocol.
  7. There are contraindications to arterial puncture, such as but not limited to severe arteriosclerosis or even atresia, coagulation dysfunction, long-term use of anticoagulants and cannot be stopped, etc.
  8. Obstruction or high risk of obstruction by rectal tumor and/or bleeding and/or perforation.
  9. Peripheral sensory nerve disorder, unable to receive oxaliplatin-based chemotherapy.
  10. Lateral pelvic lymph node metastasis (mainly supplied by the internal iliac artery).
  11. Pregnancy or breastfeeding.
  12. Contraindications for MRI。
  13. Consecutive use of corticosteroids for more than 3 days within 1 month before signing the consent form。
  14. MRI assessment was T4b or MRF positive。
  15. Other scenarios deemed inappropriate by the investigators for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging Tumor Regression Rate
Time Frame: From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)
Tumor regression on imaging after neoadjuvant therapy
From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response
Time Frame: From date of the start of drugs treatment until the operation is completed (nearly 4 weeks)
There is no histological evidence of malignancy in the primary tumor and metastatic regional lymph nodes, or there is only a carcinoma in situ component
From date of the start of drugs treatment until the operation is completed (nearly 4 weeks)
Disease Free Survival
Time Frame: 36 months
Time from postoperative disease-free survival to disease recurrence or metastasis
36 months
Safety (The side effects)
Time Frame: 36 months
The side effects of this study
36 months
Pathological Tumor Regression Rate
Time Frame: From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)
Tumor regression on pathology after neoadjuvant therapy
From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 12, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2022129

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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