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

NCT05420584 | Unknown Phase 2

• 1 other identifier: K2022129
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Imaging Tumor Regression Rate

  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 Outcomes (4)

• Pathologic Complete Response

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

• Disease Free Survival

  36 months

• Safety (The side effects)

  36 months

• Pathological Tumor Regression Rate

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

Study Arms (1)

experimental arm

EXPERIMENTAL

Procedure: Arterial chemoembolization; Drug: Tislelizumab Injection; Drug: XELOX; Diagnostic Test: Pelvic MRI; Procedure: Laparoscopic radical resection of rectal cancer

Interventions

Arterial chemoembolization PROCEDURE

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.

experimental arm

Tislelizumab Injection DRUG

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

experimental arm

XELOX DRUG

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.

experimental arm

Pelvic MRI DIAGNOSTIC_TEST

Pelvic MRI to evaluate efficacy

experimental arm

Laparoscopic radical resection of rectal cancer PROCEDURE

Surgical treatment for patients who meet the surgical conditions

experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 21876084 BACKGROUND

• 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.

  PMID: 32251400 RESULT

• Fan Y, Zhu X, Xu C, Ding C, Hu J, Hong Q, Wang J. Neoadjuvant Arterial Embolization Chemotherapy Combined PD-1 Inhibitor for Locally Advanced Rectal Cancer (NECI Study): a protocol for a phase II study. BMJ Open. 2023 Mar 13;13(3):e069401. doi: 10.1136/bmjopen-2022-069401.

  PMID: 36914193 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

tislelizumab; XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 15, 2022
• Study Start: November 29, 2022
• Primary Completion: November 30, 2024
• Study Completion: October 31, 2025
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

CN (1)