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

Primary Purpose

Locally Advanced Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Short-course radiotherapy
Capecitabine+Oxaliplatin
Sponsored by
Hebei Medical University Fourth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Cancer focused on measuring Locally advanced rectal cancer, Neoadjuvant radiotherapy, Immune checkpoint inhibitors, Programmed death-1 inhibitor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fourth Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)

Short-course radiotherapy sequential CapeOX (group B)

Arm Description

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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.

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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.

Outcomes

Primary Outcome Measures

Pathological complete response rate
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)

Secondary Outcome Measures

major pathologic response (TRG0+TRG1)
TRG 0 indicates no remaining viable cancer cells (complete response); TRG 1 indicates a single cell or small groups of cancer cells (moderate response)
3-year PFS
PFS refers to the time from randomization to tumor progresses or death from any cause
3-year OS
OS refers to the time from randomization to death from any cause
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during treatment, including chemoradiotherapy, immunology, sugery

Full Information

First Posted
September 15, 2021
Last Updated
September 13, 2023
Sponsor
Hebei Medical University Fourth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05086627
Brief Title
Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Fourth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before SCRT, and blood lymphocyte subgroups were analyzed before SCRT, systemic therapy, and surgery. 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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases. 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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases. Endpoint: The primary endpoint was pCR rate. Secondary endpoints included MPR (TRG0+TRG1), 3-year PFS, 3-year OS, and treatment safety. Follow-up records during treatment: For the duration of operation, the time required to complete the TME surgery and the amount of blood loss were recorded, and the impact of neoadjuvant therapy on the operation was observed. During the SCRT process, and the period of resting after SCRT, of the entire preoperative systemic treatment, of the resting after TME surgery, of the postoperative chemotherapy (these willing cases), the occurrence of adverse events (AE) of participants were closely monitored and actively responded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
Keywords
Locally advanced rectal cancer, Neoadjuvant radiotherapy, Immune checkpoint inhibitors, Programmed death-1 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)
Arm Type
Experimental
Arm Description
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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.
Arm Title
Short-course radiotherapy sequential CapeOX (group B)
Arm Type
Active Comparator
Arm Description
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 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Patients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin).
Intervention Type
Radiation
Intervention Name(s)
Short-course radiotherapy
Intervention Description
Patients were treated with short-course neoadjuvant radiotherapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine+Oxaliplatin
Intervention Description
Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).
Primary Outcome Measure Information:
Title
Pathological complete response rate
Description
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)
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
major pathologic response (TRG0+TRG1)
Description
TRG 0 indicates no remaining viable cancer cells (complete response); TRG 1 indicates a single cell or small groups of cancer cells (moderate response)
Time Frame
1 week after surgery
Title
3-year PFS
Description
PFS refers to the time from randomization to tumor progresses or death from any cause
Time Frame
3 years from randomization
Title
3-year OS
Description
OS refers to the time from randomization to death from any cause
Time Frame
3 years from randomization
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during treatment, including chemoradiotherapy, immunology, sugery
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, abdominal and pelvic enhanced MRI was T1-2N+M0 and cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used); 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linlin Xiao, MD
Phone
0311-86095361
Email
drxiaolinlin@163.com
Facility Information:
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxia Wang, MD
Phone
86-13933105988
Email
mxia_wang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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