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

Primary Purpose

Rectal Neoplasms

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Arterial chemoembolization

Tislelizumab Injection

XELOX

Pelvic MRI

Laparoscopic radical resection of rectal cancer

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Refuse to participate in this study.
Multifocal colorectal cancer.
Past history of malignancy, excluding basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ.
Inability to receive chemotherapy, such as but not limited to bone marrow suppression, etc.
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.
Mental disability or illiteracy or language and communication barriers cannot understand the research protocol.
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.
Obstruction or high risk of obstruction by rectal tumor and/or bleeding and/or perforation.
Peripheral sensory nerve disorder, unable to receive oxaliplatin-based chemotherapy.
Lateral pelvic lymph node metastasis (mainly supplied by the internal iliac artery).
Pregnancy or breastfeeding.
Contraindications for MRI。
Consecutive use of corticosteroids for more than 3 days within 1 month before signing the consent form。
MRI assessment was T4b or MRF positive。
Other scenarios deemed inappropriate by the investigators for this study.

Sites / Locations

The Fourth Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental arm

Arm Description

Outcomes

Primary Outcome Measures

Imaging Tumor Regression Rate

Tumor regression on imaging after neoadjuvant therapy

Secondary Outcome Measures

Pathologic Complete Response

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

Disease Free Survival

Time from postoperative disease-free survival to disease recurrence or metastasis

Safety (The side effects)

The side effects of this study

Pathological Tumor Regression Rate

Tumor regression on pathology after neoadjuvant therapy

Full Information

NCT ID

NCT05420584

First Posted

June 12, 2022

Last Updated

May 9, 2023

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05420584

Brief Title

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

Acronym

NECI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 29, 2022 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental arm

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Arterial chemoembolization

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tislelizumab Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

XELOX

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Pelvic MRI

Intervention Description

Pelvic MRI to evaluate efficacy

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic radical resection of rectal cancer

Intervention Description

Surgical treatment for patients who meet the surgical conditions

Primary Outcome Measure Information:

Title

Imaging Tumor Regression Rate

Description

Tumor regression on imaging after neoadjuvant therapy

Time Frame

From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

Secondary Outcome Measure Information:

Title

Pathologic Complete Response

Description

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

Time Frame

From date of the start of drugs treatment until the operation is completed (nearly 4 weeks)

Title

Disease Free Survival

Description

Time from postoperative disease-free survival to disease recurrence or metastasis

Time Frame

36 months

Title

Safety (The side effects)

Description

The side effects of this study

Time Frame

36 months

Title

Pathological Tumor Regression Rate

Description

Tumor regression on pathology after neoadjuvant therapy

Time Frame

From date of the start of drugs treatment until the end of drugs treatment (nearly 3 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Refuse to participate in this study. Multifocal colorectal cancer. Past history of malignancy, excluding basal cell carcinoma/papillary thyroid carcinoma/various types of carcinoma in situ. Inability to receive chemotherapy, such as but not limited to bone marrow suppression, etc. 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. Mental disability or illiteracy or language and communication barriers cannot understand the research protocol. 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. Obstruction or high risk of obstruction by rectal tumor and/or bleeding and/or perforation. Peripheral sensory nerve disorder, unable to receive oxaliplatin-based chemotherapy. Lateral pelvic lymph node metastasis (mainly supplied by the internal iliac artery). Pregnancy or breastfeeding. Contraindications for MRI。 Consecutive use of corticosteroids for more than 3 days within 1 month before signing the consent form。 MRI assessment was T4b or MRF positive。 Other scenarios deemed inappropriate by the investigators for this study.

Facility Information:

Facility Name

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

City

Yiwu

State/Province

Zhejiang

ZIP/Postal Code

322000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yiqun Fan

Phone

+86-579-89935997

632921213@qq.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

21876084

Citation

Patel UB, Taylor F, Blomqvist L, George C, Evans H, Tekkis P, Quirke P, Sebag-Montefiore D, Moran B, Heald R, Guthrie A, Bees N, Swift I, Pennert K, Brown G. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol. 2011 Oct 1;29(28):3753-60. doi: 10.1200/JCO.2011.34.9068. Epub 2011 Aug 29.

Results Reference

background

PubMed Identifier

32251400

Citation

Chalabi M, Fanchi LF, Dijkstra KK, Van den Berg JG, Aalbers AG, Sikorska K, Lopez-Yurda M, Grootscholten C, Beets GL, Snaebjornsson P, Maas M, Mertz M, Veninga V, Bounova G, Broeks A, Beets-Tan RG, de Wijkerslooth TR, van Lent AU, Marsman HA, Nuijten E, Kok NF, Kuiper M, Verbeek WH, Kok M, Van Leerdam ME, Schumacher TN, Voest EE, Haanen JB. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med. 2020 Apr;26(4):566-576. doi: 10.1038/s41591-020-0805-8. Epub 2020 Apr 6.

Results Reference

result

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

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