- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928807
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)
A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Zhenyu Lin, MD
- Phone Number: 027-85871982
- Email: whxhlzy@hust.edu.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed T3-44 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging (8th Edition, 2017);
- 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;
- Surgical treatment is planned after neoadjuvant treatment;
- There was no operative contraindication;
Laboratory tests were required to meet the following requirements:
white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Males or females with reproductive ability who are willing to use contraception in the trial;
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 radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Received live attenuated vaccine within 4 weeks before the first use of the study drug; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- 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;
- 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;
- Female subject who is pregnant or breastfeeding;
- Patients who are not suitable for participation in clinical trials in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short course radiotherapy sequential camrelizumab and chemotherapy
Radiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX and camrelizumab, for 2 cycles. The patients were operated within 10 weeks after the last radiotherapy, and the surgical method is total mesorectal excision. Postoperative adjuvant therapy will be started 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX + camrelizumab) for 6 cycles |
Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation
|
Active Comparator: Long term concurrent chemoradiotherapy and sequential chemotherapy
The patients received neoadjuvant therapy of CAPOX 2 weeks after long-term concurrent chemoradiotherapy (28*1.8Gy, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week). The patients were operated within 10 weeks after the last radiotherapy. Adjuvant therapy should begin within 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX) for 6 cycles |
Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological complete response (pCR) rate
Time Frame: an expected average of 5 months
|
Pathological complete response rate (PCR) assessed by the blind Independent Review Committee, defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
|
an expected average of 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year event-free survival rate
Time Frame: an expected average of 3 years
|
The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up
|
an expected average of 3 years
|
Overall Survival
Time Frame: an expected average of 5 years
|
The time from the date of randomization to the death caused by any cause
|
an expected average of 5 years
|
R0 resection rate
Time Frame: an expected average of 2 years
|
The rate of negative margin microscopically
|
an expected average of 2 years
|
3-year disease-Free Survival
Time Frame: an expected average of 3 years
|
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first
|
an expected average of 3 years
|
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time Frame: an expected average of 1.5 years
|
Adverse events and surgical safety
|
an expected average of 1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tao Zhang, MD, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MA-CRC-Ⅲ-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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