Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer

  • STATUS
    Recruiting
  • End date
    May 15, 2026
  • participants needed
    100
  • sponsor
    Hebei Medical University Fourth Hospital
Updated on 4 October 2022

Summary

This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.

Description

Subjects in group A will be treated according to the following treatment plan:

Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with Tislelizumab (days 11, 33, 55, 77) and neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).

Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment) Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.

Subjects in group B will be treated according to the following treatment plan:

Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).

Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment.

Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.

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)

Details
Condition Locally Advanced Rectal Cancer
Treatment tislelizumab, Short-course Radiotherapy, Capecitabine+Oxaliplatin
Clinical Study IdentifierNCT05086627
SponsorHebei Medical University Fourth Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients or their family members agree to participate in the study and sign the informed
consent form
Patients ≥ 18 and ≤75 years old, male or female
ECOG performance status of 0 or 1
Patients with histologically confirmed rectal adenocarcinoma
The clinical diagnosis of chest CT, abdomen and enhanced MRI was cT3/T4a, Nany, M0
The distance between the lower edge of the tumor and the anal edge is less than or equal to
cm
No history of immune system diseases
No history of immunodeficiency, including HIV positive
No history of other malignancies
No history of myocarditis
No history of cardiovascular and cerebrovascular diseases
No history of thyroid dysfunction
No history of liver and kidney diseases
No history of mental illness, no history of Infectious diseases
No history of organ transplantation or allogeneic bone marrow transplantation
There is no history of other systemic diseases other than the above diseases
Voluntarily accept the neoadjuvant treatment scheme of radiotherapy, sequential
chemotherapy / chemotherapy combined with immunotherapy
Rectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor
Swallowing pills normally
treatment, etc
Surgical treatment is planned after neoadjuvant treatment

Exclusion Criteria

Patients who do not meet the above inclusion criteria
Documented history of allergy to study drugs, including any component of Tislelizumab
capecitabine, oxaliplatin and other platinum drugs
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; Major surgery or severe trauma within 4 weeks before the first use of the
study drug
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 who refuse to sign informed consent by themselves or their authorized persons
Female patients who is pregnant or breastfeeding
Patients with poor cognitive ability, unable to answer questions, unable to fill in
questionnaires or mental disorders
Patients considered unsuitable for the study by the investigator
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