Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Chao Yang Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Peking Union Medical College Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR | complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients | pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins |
| Measure | Description | Time Frame |
|---|---|---|
| AE rate | Adverse event rate | during treatment |
| NAR score | Neoadjuvant rectal(NAR)score:It is based on the scoring criteria of preoperative treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;
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;
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;
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;
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;
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;
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);
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;
Women in pregnancy or lactation;
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongtao Zhang, MD | Contact | +86 13801060364 | Zhangzht@ccmu.edu.cn | |
| Hongwei Yao | Contact | +8613611015609 | yaohongwei@ccmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| 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 |
| The Second Affiliated Hospital of Air Force Military Medical University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| 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, China | OTHER |
| 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 Cancer Center | OTHER |
| Zhejiang Tumor Hospital | OTHER |
| Ruijin Hospital | OTHER |
| 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 |
Not provided
Not provided
Not provided
Not provided
| within 10 days after surgery |
| ORR | objective response rate objective response rate objective response rate objective response rate | within 10 days after surgery |
| OPR | organ preservation rate organ preservation rate organ preservation rate | immediately after surgery |
| immune-related adverse event rate | adverse event rate that is deemed to be associated with tislelizumab | up to 3 weeks after using tislelizumab |
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
|