Combination of arterial chemotherapy and PD-1 inhibitor for advanced rectal cancer

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

This study is testing a new treatment that combines a special type of chemotherapy with an immune booster for people with advanced rectal cancer to see if it helps them have better surgery results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Yiwu, Zhejiang)
• Trial ID: NCT05420584 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of neoadjuvant arterial embolization chemotherapy combined with a PD-1 inhibitor, Tislelizumab, for patients with locally advanced rectal cancer. The approach aims to enhance the effectiveness of treatment prior to surgical resection by targeting the tumor more directly while minimizing systemic side effects. Patients will undergo imaging assessments and receive a combination of chemotherapy and immunotherapy to evaluate the potential for improved surgical outcomes. The study focuses on patients with specific tumor characteristics and aims to determine the safety and efficacy of this combined treatment strategy.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed rectal adenocarcinoma who have specific MRI staging and no distant metastasis.

Not a fit: Patients with multifocal colorectal cancer or significant comorbidities that prevent them from receiving chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and reduce recurrence rates in patients with locally advanced rectal cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches combining targeted therapies and immunotherapy in various cancers, indicating potential for success in this novel application.

Eligibility criteria

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.

Where this trial is running

Yiwu, Zhejiang

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)

Conditions Rectal Neoplasms