TIME in Immunotherapy Combined With nCRT for Rectal Cancer

• Status: Not yet recruiting
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Capecitabine; Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

3. Histologically proven rectal adenocarcinoma.

4. <12 cm from anal verge.

5. Clinical stage of T3/T4 or N positive and M0

6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment

7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.

8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.

9. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Allergic to any component of chemotherapy or immunotherapy;

2. Patients with multiple primary colorectal cancer;

3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ;

4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, and other conditions requiring emergency surgical resection;

5. Prior or planed organ/bone marrow transplant

6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;

7. Pregnant or lactating women

8. Any psychiatric condition that would prohibit the understanding or rendering of informed consent.

9. Patients who have contradictions to chemoradiotherapy, immunotherapy and surgery.

10. The investigator judges that the patient is not suitable to participate in other situations.