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

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ClinicalTrials.gov Identifier: NCT05086627
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

Tracking Information
First Submitted Date  ICMJE September 15, 2021
First Posted Date  ICMJE October 21, 2021
Last Update Posted Date October 21, 2021
Estimated Study Start Date  ICMJE October 15, 2021
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2021)
Pathological complete response rate [ Time Frame: A week after surgery ]
Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
Official Title  ICMJE A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
Brief 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.
Detailed 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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Rectal Cancer
Intervention  ICMJE
  • Drug: Tislelizumab
    Patients were treated with Tislelizumab (days 11, 33, 55, 77)
  • Radiation: Short-course radiotherapy
    Patients were treated with short-course neoadjuvant radiotherapy
  • Drug: Capecitabine+Oxaliplatin
    Patients were treated with neoadjuvant chemoherapy with CapeOX
Study Arms  ICMJE
  • Experimental: Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

    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.

    Interventions:
    • Drug: Tislelizumab
    • Radiation: Short-course radiotherapy
    • Drug: Capecitabine+Oxaliplatin
  • Active Comparator: Short-course radiotherapy sequential CapeOX (group B)

    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.

    Interventions:
    • Radiation: Short-course radiotherapy
    • Drug: Capecitabine+Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2026
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 10 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;

Swallowing pills normally;

Rectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor 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;

Female patients who is pregnant or breastfeeding;

Patients who refuse to sign informed consent by themselves or their authorized persons;

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linlin Xiao, MD 0311-86095361 drxiaolinlin@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05086627
Other Study ID Numbers  ICMJE 2021104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hebei Medical University Fourth Hospital
Study Sponsor  ICMJE Hebei Medical University Fourth Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hebei Medical University Fourth Hospital
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP