A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
NCT ID: NCT06312982
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
375 participants
INTERVENTIONAL
2024-03-16
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
The enrolled patients 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. Eight to 8-10 weeks after the completion of radiation therapy, patients will undergo multiple examinations, including colonoscopy and MRI. Subsequent treatment options will be determined by each center physician based on their clinical experience.
Tislelizumab
Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.
Control group
This group required only 5 weeks of NCRT and 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.
No interventions assigned to this group
Interventions
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Tislelizumab
Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
China-Japan Friendship Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Fudan University
OTHER
Changhai Hospital
OTHER
RenJi Hospital
OTHER
Sir Run Run Shaw Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
Zhongnan Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Sichuan Academy of Medical Sciences
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
The First Hospital of Jilin University
OTHER
First Hospital of China Medical University
OTHER
Xijing Hospital of Airforce Medical University
UNKNOWN
Tangdu Hospital-Air Force Medical University
UNKNOWN
The Affiliated Hospital of Qingdao University
OTHER
Daping Hospital, the Third Military Medical University
UNKNOWN
Tianjin Union Medical Center
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
The Affiliated Tumour Hospital of China Academy of Medical Science
UNKNOWN
Rocket Force Characteristic Medical Center
UNKNOWN
Tianjin Medical University General Hospital
OTHER
The Second Affiliated Hospital of Naval Medical University
UNKNOWN
West China Hospital
OTHER
Southern Medical University - Southern Hospital
UNKNOWN
First Affiliated Hospital of Chongqing Medical University
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Hebei Medical University Fourth Hospital
OTHER
Sun Yat-sen University
OTHER
Zhejiang Tumor Hospital
OTHER
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
UNKNOWN
Beijing Hospital of the Ministry of Health
UNKNOWN
Queen Mary Hospital, Hong Kong
OTHER
The University of Hong Kong-Shenzhen Hospital
OTHER
Taiwan Hexin Cancer Center Hospital
UNKNOWN
First Affiliated Hospital of Wenzhou Medical University
OTHER
Beijing Friendship Hospital
OTHER
Responsible Party
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Zhongtao Zhang
The professor
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BFH-niCRT-04
Identifier Type: -
Identifier Source: org_study_id
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