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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT followed by tislelizumab plus cetuximab and irinotecan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR | From enrollment to 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) | PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first | From enrollment to 12 month |
| Overall Survival (OS) |
Not provided
Inclusion Criteria:
Aged 18-75 years
Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1;
Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery
Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment;
Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability;
At least one measurable lesion as defined in RECIST version 1.1;
Fertile patients must be willing to take effective pregnancy avoidance measures during the study period and ≥120 days after the last dose; Female patients with negative urine or serum pregnancy test results within 7 days or less before the first administration of the study drug;
Have fully understood this study and voluntarily signed informed consent.
Adequate organ and bone marrow function, meeting the following definitions:
Exclusion Criteria:
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
Not provided
Not provided
| Irinotecan Hydrochloride | Drug | Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days. |
|
| cetuximab | Drug | cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days. |
|
| SBRT | Radiation | 8-10Gy×5F,QOD |
|
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. |
| From enrollment to 12 month |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000077146 | Irinotecan |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
Not provided
Not provided