TIME in Immunotherapy Combined With nCRT for Rectal Cancer

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 16, 2022

Keywords

ClinConnect Summary

The TIME trial is a clinical study designed to explore a new treatment approach for patients with locally advanced rectal cancer. Specifically, it looks at combining immunotherapy (a treatment that helps the immune system fight cancer) with chemoradiotherapy (a mix of chemotherapy and radiation) before surgery. The main goal is to see how many patients achieve a complete response to the treatment, meaning no signs of cancer are left. The study will also track any long-term effects and side effects from the treatment.

To participate in the trial, patients need to be between 18 and 75 years old and have been diagnosed with a specific type of rectal cancer that hasn't been treated before. They must also be in good overall health, without certain autoimmune diseases or previous cancer treatments. The trial is currently not recruiting participants, but once it starts, those who qualify can expect regular check-ups and assessments to monitor their response to the treatment. This trial aims to better understand how the immune environment around tumors can influence treatment outcomes, potentially leading to improved care for rectal cancer patients in the future.

Gender

ALL

Eligibility 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 of breast;
• • 4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or 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. Patients with a history of severe mental illness or being unable to comply with the research protocols.
• • 9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.
• • 10. Patients who have any other conditions that investigator judges unsuitable to participate.