Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanc… (NCT04928807) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)
China231 participantsStarted 2021-07-20
Plain-language summary
The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term concurrent chemoradiotherapy, sequential CAPOX (group B) in patients with LARC. A total of 230 patients were included in this study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients or their family members agree to participate in the study and sign the informed consent form;
✓. inferior margin ≤ 10 cm from the anal verge;
✓. It is expected to reach R0;
✓. ECOG performance status score is 0-1;
✓. Swallowing pills normally;
✓. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;
Exclusion criteria
✕. Documented history of allergy to study drugs, including any component of Camrelizumab, capecitabine, irinotecan, oxaliplatin and other platinum drugs;
✕. Have received or are receiving any of the following treatments:
✕. Any active autoimmune disease or history of autoimmune disease;
✕. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
✕
What they're measuring
1
pathological complete response (pCR) rate
Timeframe: an expected average of 5 months
Trial details
NCT IDNCT04928807
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
. There are clinical symptoms or diseases of heart that are not well controlled;
✕. Severe infection (CTCAE \> 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
✕. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within one year before enrollment, or with a history of active pulmonary tuberculosis infection more than one year ago but without regular treatment;
✕. The presence of active hepatitis B (HBV DNA \> 2000 IU/mL or 104 copies/mL) was positive for hepatitis C (hepatitis C antibody) and HCV RNA was higher than the lower limit of analytical method;