Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

NCT05245474

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Led by Beijing Friendship Hospital · Updated on 2024-01-10

186

Participants Needed

Research Sites

387 weeks

Total Duration

AI-Summary

What this Trial Is About

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

CONDITIONS

Official Title

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 to 75 years
ECOG performance status score between 0 and 2
Biopsy-confirmed rectal adenocarcinoma with distal margin within 10 cm of the anal verge
No distant metastasis, staged II or III excluding T4b by MRI
Rectal cancer lesion diameter of at least 10 mm on baseline CT or MRI
Willing and able to follow the study protocol
Consent to use of blood and tissue samples for research
No previous anti-tumor treatments such as chemotherapy, radiotherapy, immunotherapy, biological therapy, or herbal treatments
No immune system diseases such as lupus, rheumatoid arthritis, vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid disorders, ulcerative colitis, HIV infection, and similar
No significant dysfunction of major organs like heart, lung, liver, or kidney
No jaundice or gastrointestinal obstruction
No acute or ongoing infections
Normal blood and biochemical test results within specified limits
No social or mental disorders
For women of childbearing potential, negative pregnancy test and effective contraception during treatment and 60 days after last dose

You will not qualify if you...

Presence of multiple cancers or other malignant tumors besides rectal cancer
Anti-cancer treatment received in the past 5 years
Recent major surgery
Conditions affecting absorption of capecitabine such as difficulty swallowing, nausea, vomiting, or chronic diarrhea
Uncontrolled or severe concurrent diseases
Allergy to any study treatment ingredients
Estimated survival of 5 years or less for any reason
Preparing for or having received organ or bone marrow transplant
Immunosuppressive or systemic hormone therapy for immunosuppression within 1 month prior to study
History of central nervous system disorders affecting consent or medication compliance
Other conditions that may affect study results or cause early treatment termination such as alcoholism or drug abuse
Pregnant or breastfeeding women or women planning to conceive during treatment

AI-Screening

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Trial Site Locations

Total: 8 locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

Beijing Cancer Hospital