Neoadjuvant chemotherapy with PD-1 antibody for advanced rectal cancer

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant MFOLFOX6 Chemotherapy in Combination with PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer (FIRM Study)

This study is testing if a combination of chemotherapy and a new type of immune therapy can help people with advanced rectal cancer shrink their tumors before surgery, without using radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06688786 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of preoperative neoadjuvant mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody therapy in patients with locally advanced rectal cancer. The aim is to induce tumor regression while avoiding the complications associated with traditional radiotherapy. By focusing on a radiation-free approach, the study seeks to improve postoperative outcomes and preserve anal function. Eligible participants include those with advanced rectal cancer who have not received prior treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced rectal cancer that is microsatellite stable and has not been previously treated with chemotherapy or radiotherapy.

Not a fit: Patients with distant metastasis or those who have received prior cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved tumor regression rates and better quality of life for patients undergoing treatment for locally advanced rectal cancer.

How similar studies have performed: While the combination of chemotherapy and PD-1 inhibitors is being explored in various cancers, this specific approach in locally advanced rectal cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Advanced (cT3-4NxM0 or cTxN+M0) rectal cancer with the lower tumor margin within 15 cm of the anal verge
2. Histopathology confirmed adenocarcinoma with an pMMR/MSS genetic profile.
3. Absence of bowel obstruction, or bowel obstruction relieved by proximal colostomy.
4. Age: 18-75
5. ECOG: 0-1
6. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy received.
7. Female participants must be non-lactating, with a negative pregnancy test result.

Exclusion Criteria:

1. Patients with distant metastasis
2. History of receiving chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
3. Active autoimmune disease requiring systemic treatment within the 2 years prior to enrollment.
4. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.
5. History of HIV infection, or active chronic hepatitis B or C with high viral DNA copy numbers.
6. Patients with active tuberculosis currently receiving anti-tuberculosis treatment or treated with anti-tuberculosis therapy within the past year prior to screening.
7. Known or suspected allergy to the study drug or any study-related medications administered.
8. Presence of severe cardiovascular or cerebrovascular disease.
9. Within 14 days prior to the first dose, presence of a severe active or uncontrolled infection requiring systemic therapy, or unexplained fever \>38.5°C.
10. Receiving systemic corticosteroid treatment or other immunosuppressive agents within 14 days prior to the first dose, or immunostimulants within 4 weeks.
11. History of confirmed neurological or psychiatric disorders, including epilepsy or dementia.
12. The participant may be unable to complete the study due to other reasons, or the investigator considers them unsuitable for inclusion.
13. Refusal to sign the informed consent form.

Where this trial is running

Shanghai, Shanghai

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Tingyu Wu, Ph.D.

Conditions Locally Advanced Rectal Cancer; rectcal cancer; microsatellite stable; FOLFOX; neoadjuvant chemotherapy; PD-1 antibodies