Trial Title:
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study
NCT ID:
NCT06312982
Condition:
Locally Advanced Rectal Carcinoma
Conditions: Official terms:
Rectal Neoplasms
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.
Arm group label:
Experimental group
Summary:
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant
chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy
alone for neoadjuvant therapy in patients with locally advanced rectal cancer.
The main questions it aims to answer are:
To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with
tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in
patients with locally advanced rectal cancer To assess rectal or anal retention as well
as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f,
capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to
tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the
first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will
be treated with two 14-day cycles of the CAPOX(Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt;
D1-D14, capecitabine, 850-1000mg / m2, BID, PO)regimen. Two CAOPX regimens were treated
one week apart.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed a written informed consent form and volunteered to join the study;
2. .Age: 18-75 years old, male or female;
3. Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical
results of pMMR or genetic test results of MSS;
4. The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-),
lateral lymph nodes (-);
5. The lower tumor margin is 10cm away from the anal margin;
6. Surgical resection;
7. Ability to swallow tablets normally;
8. ECOG PS 0-1;
9. Have not received any anti-tumor treatment for rectal cancer, including
radiotherapy, chemotherapy, surgery, etc.;
10. Plan to undergo surgery after the completion of the neoadjuvant therapy;
11. No contraindications to surgery;
12. Main organ function is normal.
Exclusion Criteria:
1. Previous history of allergy to monoclonal antibodies, any component of
tislelizumab,and capecitabine;
2. Previously has received or is receiving any of the following treatments:
A)Any tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy,
immunotherapy, etc; B)Treatment with immunosuppressive drugs or systemic hormones
within 2 weeks of first use (dose> 10mg / day prednisone or equivalent dose);
inhaled or topical steroids and dose> 10mg / day prednisone or equivalent dose of
adrenocorticoid replacement in the absence of active autoimmune disease; C)Having
received a live attenuated vaccine within 4 weeks before the first use of the study
drug; D)Major surgery or severe trauma within 4 weeks before the first use of study
drug;
3. History of any active autoimmune or autoimmune disease, including but not limited
to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis,
nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement
therapy); patients with psoriasis or asthma / allergy in childhood and adults
without any intervention, but patients requiring medical intervention with
bronchodilators should not be included;
4. A history of immunodeficiency, including a positive HIV test, or other acquired or
congenital immunodeficiency disease, or a history of organ transplantation or
allogeneic bone marrow transplantation;
5. Not well controlled cardiac clinical symptoms or disease, including but not limited
to: such as (1) grade NYHA II above heart failure, (2) unstable angina, (3)
myocardial infarction within 1 year, (4) clinical meaningful supraventricular or
ventricular arrhythmia without clinical intervention or clinical intervention still
poor control;
6. Severe infection (Grade CTCAE> 2) within 4 weeks prior to the first use of study
drug, Such as severe pneumonia, bacteremia, infection complications requiring
hospitalization; Baseline chest imaging indicated the presence of active lung
inflammation, presence of symptoms and signs and signs of infection within 14 days
prior to the first administration of study drug or need for oral or intravenous
antibiotics, Except for the preventive use of antibiotics; Found active tuberculosis
infection by history or CT, Or those with a history of active tuberculosis infection
within 1 year prior to enrollment, Or those with a history of active tuberculosis
infection more than 1 year ago but without formal treatment;
7. Presence of active hepatitis B (HBV DNA 2000 IU / mL or 104copies / mL), hepatitis C
(positive for hepatitis C antibody, and HCV RNA above the lower limit of detection
of the analytical method);
8. A diagnosis of other malignancies within 5 years prior to the first use of study
drug, unless a malignancy with low risk of metastasis or death (5-year survival>
90%), such as adequately treated skin basal cell carcinoma or squamous cell
carcinoma in situ, are considered;
9. Women in pregnancy or lactation;
10. Other factors, as judged by the investigator, may lead to forced termination of the
study, such as other serious illness (including mental illness), alcohol, substance
abuse, family or social factors, which may affect the safety or compliance of the
subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Yao Hongwei, M.D
Phone:
86 13611015609
Email:
yaohongwei@ccmu.edu.cn
Facility:
Name:
Beijing Friendship Hospital
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongtao Zhang,, MD
Phone:
+86-13801060364
Email:
zhangzht@ccmu.edu.cn
Start date:
February 20, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Chao Yang Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
CHINA-JAPEN FRIENDSHIP HOSPITAL
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Zhongnan Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
West China School of Medicine and West China Hospital, Sichuan University
Agency class:
Other
Collaborator:
Agency:
Sichuan Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
The Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
Army Medical Center of PLA
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06312982