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The purpose of this study is to acssess the efficacy and the safety of Sintilimab plus bevacizumab/cetuximab plus XELOX regimen for conversion therapy in patients with advanced colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Patients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab ,bevcizumab/cetuximab,XELOX | Drug | Patients in this group had previously received the following treatment regimens: Oxaliplatin :130 mg/m2, D1, Q3W; Capecitabine :1000mg/m2, bid q2w Sintilimab for injection :200mg, D1, Q3W Bevacizumab :7.5mg/kg, D1, Q3W or cetuximab :500 mg/m, D1, Q2W |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0 | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR): Defined as the proportion of patients who achieved a prespecified reduction in tumor volume and maintained a minimum duration, including cases with CR and PR. Objective tumor response was assessed by an independent review committee using the Response Assessment Criteria for solid Tumors (RECIST 1.1 criteria). | 1-year |
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Inclusion Criteria:
Pathological diagnosis of colorectal adenocarcinoma; Ambulatory cases, aged 18-75 years; ECOG score less than or equal to 1; Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy);
Baseline blood routine and biochemical parameters of the subjects met the following criteria:
A. TBIL 1.5 x ULN or less; B. ALT and AST & LT; 2.5×ULN, ALT and AST & LT for patients with liver metastases; 5 x ULN; C. BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min(Cockcroft-Gault formula).
No history of other tumors; Be willing and able to follow the protocol during the study; Withdraw from the study at any time during the study without any loss; No history of other tumors; Be willing and able to follow the protocol during the study; Written informed consent was provided prior to study screening and was understood by the patient; Expected life ≥ 6 months
Exclusion Criteria:
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Patients were not admitted to the study if they met any of the following criteria:
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Patients with initially unresectable advanced colorectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianjun Yang | Contact | +8613572533693 | jianjunyang66@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yang Jianjun | Recruiting | Xi’an | Shanxi | 712000 | China |
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| DCR | The proportion of all subjects who were randomized and whose best overall response (BOR) was complete response (CR), partial response (PR), and stable disease (SD) according to RECIST1.1 criteria. | 1-year |
| OS | It was defined as the time between the start of randomization and the death of the subject from any cause and was calculated in the intention-to-treat population (ITT). | 2-year |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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