Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with locally advanced rectal cancer. The researchers want to see how well a combination of long-term radiation therapy, using a medication called capecitabine, followed by three cycles of an immunotherapy drug called Sintilimab, can help patients. Immunotherapy works by helping the body’s immune system fight cancer. The trial is currently looking for participants who are between 18 and 75 years old and have been diagnosed with rectal adenocarcinoma that is not spread to other parts of the body.

To be eligible for the trial, participants should have a specific type of rectal cancer and meet certain health criteria, like having no significant heart or lung problems and no history of prior cancer treatments. Participants can expect to undergo the treatment as well as regular check-ups to monitor their health throughout the study. It’s important for potential participants to understand that they will need to provide consent for the use of their blood and tissue samples in the study. This trial offers a chance to explore new treatment options that could improve outcomes for people with this type of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • aged 18\~75
• • ECOG score 0\~2
• • biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
• • no distant metastasis, staged II/III (T4b excluded) by MRI
• • maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR
• • willing and able to comply with study protocol
• • consent to the use of blood and tissue specimens for study
• • no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
• • no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
• • no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
• • no jaundice or gastrointestinal obstruction
• • no acute/ongoing infection
• • no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
• • no social or mental disorder
• • for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required
• Exclusion Criteria:
• • multiple cancers, or with concomitant malignant tumors besides rectal cancer
• • having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
• • history of recent major surgery
• • with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
• • with uncontrolled, severe, concomitant diseases of any sort
• • allergic to any of the ingredients under study
• • estimated survival ≤ 5 years due to any reason
• • preparing for or having previously received organ or bone marrow transplant
• • having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion
• • for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance
• • with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
• • pregnant or lactating women, or women intending on conception during treatment period