Trial Title:
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
NCT ID:
NCT06017583
Condition:
Rectal Neoplasms
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Tislelizumab
Conditions: Keywords:
Rectal cancer
Tislelizumab
SIB IMRT
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The random number table method.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tirellizumab was administered intravenously at 200mg/d1, 21 days per cycle, with at least
4 cycles completed.
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Oral capecitabine 825mg/m2 bid, radiotherapy day concurrent chemotherapy. Chemotherapy
regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion of
130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2 cycles
completed.
Arm group label:
Control arm
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Chemotherapy regimen after radiotherapy: XELOX regimen: oxaliplatin intravenous infusion
of 130mg/m2/d1+ oral capecitabine 1000mg/m2 bid/ d1-14, 21 days per cycle, at least 2
cycles completed.
Arm group label:
Control arm
Arm group label:
Experimental arm
Intervention type:
Radiation
Intervention name:
SIB-IMRT
Description:
The tumor and the related mesenteric region 1cm above and below were simultaneously
integrated boost to 5600cGy with the intensity-modulated radiotherapy. The other dose for
clinical target volume is 5000 cGy.
Arm group label:
Experimental arm
Intervention type:
Radiation
Intervention name:
IMRT
Description:
The whole dose of the clinical target volume is 5000 cGy with intensity-modulated
radiotherapy.
Arm group label:
Control arm
Summary:
This study aims to evaluate the efficacy and safety of tislelizumab combined with
simultaneous integrated boost intensity-modulated radiotherapy in treating locally
advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model
combined with radiotherapy to treat locally advanced rectal cancer.
Detailed description:
This is a randomized controlled trial (RCT). Patients with T3-4 in the 8th AJCC stage or
positive regional lymph nodes and no distant metastases will be enrolled. Forty-eight
patients will be enrolled by inclusion and exclusion criteria. The enrolled patients will
be randomly divided into experimental and control groups (twenty-four patients for each
group) to receive preoperative neoadjuvant therapy. The experimental group will receive
concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) and
concurrent capecitabine chemotherapy, and complete 2 ~ 4 cycles of XELOX chemotherapy,
while receiving complete tislelizumab treatment for at least 4 cycles (21 days per
cycle). The control group received intensity-modulated radiotherapy (IMRT) without
tirellizumab, and the other treatment regiments were consistent with the experimental
group. The tumor size will be measured in MRI or CT images, and side effects will be
recorded. The primary outcome was CR rate (pathological complete response rate and
clinical complete response rate), and secondary outcomes were side effects and 3-year OS
and DFS.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18 to 70 years.
2. The pathological type of rectal cancer diagnosed by histopathology is
adenocarcinoma.
3. Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no
distant metastasis.
4. Having at least one measurable lesion according to RECIST 1.1.
5. ECOG score 0-1.
6. Expected survival time ≥6 months.
7. Major organ function is normal, that is, meeting the following criteria: blood
routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of
ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine
clearance ≥60 ml/min.
8. Subjects volunteered to join the study, signed the informed consent, had good
compliance, and cooperated with follow-up.
Exclusion Criteria:
1. Patients have had or currently have other malignant tumors within 5 years.
2. Patients allergic or sensitive to any drug in the study protocol.
3. Patients innate or acquired immune deficiency (e.g. HIV infection).
4. The presence of any active, known or suspected autoimmune disease (such as, but not
limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis,
nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); The subject had
vitiligo. Subjects with asthma require bronchodilators for medical intervention.
5. The presence of active infections requiring systemic treatment.
6. The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy,
or other drug therapy targeting immunoregulatory receptor preparations.
7. Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment,
excluding alopecia.
8. Patients with a history of myocardial infarction or stroke, unstable angina
pectoris, decompensated heart failure or deep vein thrombosis.
9. Patients with long-term untreated wounds or fractures, major surgical operations or
severe traumatic injuries, fractures or ulcers within 4 weeks.
10. Pregnant or lactating women.
11. Patients with liver and kidney dysfunction.
12. Patients with a history of abuse of psychotropic drugs and unable to abstain or
patients with mental disorders.
13. Patients who have participated in clinical trials of other drugs within 4 weeks.
14. Patients with concomitant diseases that, in the judgment of the investigator,
seriously endanger the patient's safety or affect the patient's completion of the
study.
15. The investigator judged that participation in this study was not conducive to the
maximum benefit of the subjects.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yong Zhang, PhD
Phone:
13607884001
Email:
zhangyonggx@163.com
Contact backup:
Last name:
Shanshan Ma, PhD
Phone:
13557994302
Email:
mashanshan@gxmu.edu.cn
Start date:
September 1, 2023
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Yong Zhang,MD
Agency class:
Other
Source:
First Affiliated Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06017583
