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To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (SCRT) followed by PD-1+ standard therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 | Drug | Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | The length of time from enrollment until the time of progression of disease (PFS, progression-free survival). | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate). | every 3 months (up to 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| SCRT | Radiation | Radiotherapy dose: 5×5 Gy |
|
| Bevacizumab | Drug | Participants will receive bevacizumab,5mg/kg,intravenously over 60 - 90 minutes, day 1 of every 2 weeks |
|
| Oxaliplatin | Drug | Participants will receive Oxaliplatin,85mg/m2,day1 |
|
| Calcium folinate | Drug | Participants will receive calcium folinate ,400mg/m2,day1 |
|
| 5-fluorouracil | Drug | Participants will receive 5-fluorouracil ,400mg/m2,day1 |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |