Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

Last updated: December 31, 2023
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Not Recruiting

Phase

3

Condition

Colon Cancer

Rectal Cancer

Rectal Disorders

Treatment

Short course radiotherapy sequential camrelizumab and chemotherapy

Clinical Study ID

NCT04928807
MA-CRC-Ⅲ-006
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients or their family members agree to participate in the study and sign theinformed consent form;
  2. Age 18-75 years, male or female;
  3. Histologically confirmed T3-44 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging (8th Edition, 2017);
  4. inferior margin ≤ 10 cm from the anal verge;
  5. It is expected to reach R0;
  6. ECOG performance status score is 0-1;
  7. Swallowing pills normally;
  8. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy,chemotherapy, surgery, etc;
  9. Surgical treatment is planned after neoadjuvant treatment;
  10. There was no operative contraindication;
  11. 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 × upperlimit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit ofnormal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
  12. Males or females with reproductive ability who are willing to use contraception in thetrial;

Exclusion

Exclusion Criteria:

  1. Documented history of allergy to study drugs, including any component of Camrelizumab,capecitabine, irinotecan, oxaliplatin and other platinum drugs;
  2. Have received or are receiving any of the following treatments: Any radiotherapy, chemotherapy or other anti-tumor drugs for tumor; Patients who needto be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) orother immunosuppressive agents within 2 weeks prior to study drug administration;Received live attenuated vaccine within 4 weeks before the first use of the studydrug; Major surgery or severe trauma within 4 weeks before the first use of the studydrug;
  3. Any active autoimmune disease or history of autoimmune disease;
  4. Have a history of immunodeficiency, including HIV positive, or other acquired orcongenital immunodeficiency diseases, or have a history of organ transplantation orallogeneic bone marrow transplantation;
  5. There are clinical symptoms or diseases of heart that are not well controlled;
  6. Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the studydrug; Baseline chest imaging revealed active pulmonary inflammation, signs andsymptoms of infection within 14 days prior to the first use of the study drug, or oralor intravenous antibiotic therapy, except for prophylactic use of antibiotics;
  7. Patients with active pulmonary tuberculosis infection found by medical history or CTexamination, or with a history of active pulmonary tuberculosis infection within oneyear before enrollment, or with a history of active pulmonary tuberculosis infectionmore than one year ago but without regular treatment;
  8. The presence of active hepatitis B (HBV DNA > 2000 IU/mL or 104 copies/mL) waspositive for hepatitis C (hepatitis C antibody) and HCV RNA was higher than the lowerlimit of analytical method;
  9. Female subject who is pregnant or breastfeeding;
  10. Patients who are not suitable for participation in clinical trials in the opinion ofthe investigator

Study Design

Total Participants: 231
Treatment Group(s): 1
Primary Treatment: Short course radiotherapy sequential camrelizumab and chemotherapy
Phase: 3
Study Start date:
July 20, 2021
Estimated Completion Date:
March 20, 2026

Study Description

Patients with locally advanced rectal cancer (T3-4/N+) were randomly assigned to experimental group A or control group B according to the ratio of 1:1,who will receive preoperative neoadjuvant therapy, and the Primary endpoint of the study is Pathological complete response rate(PCR ) assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)

Connect with a study center

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

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