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This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment | Experimental | CapeOx: Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 130mg / m² on Day 1 every 3 weeks for 4 cycles; Bevacizumab:Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles; Tislelizumab:Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Percentage of patients who achieve partial response (PR) or complete response (CR) | 15 weeks |
| R0 resection rate | Percentage of patients who achieve R0 resection | 15 weeks |
| Pathological complete response rate | Percentage of patients who achieve pathological complete response (pCR) based on local investigator | 15 weeks |
| Tumor regression grade (TRG) | 15 weeks | |
| Incidence of Treatment-Related Adverse Events | Number of adverse events | Until 30 days after the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Until 90 days after surgery | |
| Quality of life score (QoL score) | Assessment of life quality based on EORTC QLQ-C30 | Until 30 days after the last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyang Zhou, MD | Contact | +86 81885615 | haiyang1985_1@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | China |
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| Oxaliplatin | Drug | Oxaliplatin is given by intravenous infusion at 130mg / m² on Day 1 every 3 weeks for 4 cycles |
|
| Bevacizumab | Drug | Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles |
|
| Tislelizumab | Drug | Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles |
|
| Event free survival | Measure of time from study treatment to disease progression or death | Up to 3 years |
| Disease-free survival | Measure of time from the date of surgery to disease relapse or death | Up to 3 years |
| One-year or two-year disease-free survival rate | Percentage of patients who achieve disease-free survival lasting for more than one and two years respectively from the date of surgery | Up to 2 years |
| One-year or two-year overall survival rate | Percentage of patients who achieve survival for more than one and two years respectively from date of first dose | Up to 2 years |
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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