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In recent years, growing evidences have demonstrated promising synergistic antitumor effects of radiotherapy combined with immunotherapy. More over, LDRT may enhance the antitumor effect of immunotherapy by altering the tumor immune microenvironment (TIME) and adjusting the immune response. In this study, we will explore the safety and feasibility of LDRT and immunochemotherapy in liver metastatic colorectal cancer. 9-18 participants will be enrolled in this study. All will take part at Daping Hospital, Army Medical University.
This is a prospective, single-arm, phase Ib trial. At least 9 eligible patients will be will be enrolled In this study. Patients will receive LDRT of 10 Gy in 5 fractions, 15 Gy in 5 fractions, 20 Gy in 10 fractions respectively in our three groups on liver metastsis from Day1 (patients with rectal cancer will receive SCRT concurrently), followed by Xelox and Tislelizumab starting from 1 week after the completion of radiation. The primary endpoints are safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDRT/LDRT+SCRT followed by Tislelizumab+XELOX | Experimental | For patients with colon Cancer: LDRT starts from day 1. For patients with rectal Cancer: LDRT and SCRT start concurrently from day 1. Tislelizumab+XELOX start from 1week after the completion of radiotherapy (2-4 cycles). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Dose Radiotherapy | Radiation | 10 Gy in 5 fractions, 15 Gy in 3 fractions, 20 Gy in 10 fractions respectively in three Cohorts from Day1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and tolerability of LDRT in Combination With Tirellizumab and XELOX | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Investigator assessed ORR using RECIST v1.1 including the all tumor | 2 years |
| Progression-free survival (PFS) | Defined as the time from initiation of treatment to tumor progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuan Chen, MD PhD | Contact | 13883089634 | sinkriver@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuan Chen, MD PhD | Daping Hospital, Army Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Army Medical Center | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| Short course Radiotherapy | Radiation | 25 Gy in 5 fractions from Day1 |
|
| XELOX | Drug | Oxaliplatin: 130mg/m2 IV Q3W on day 1 of each cycle. Capecitabine: 1000mg/m2 Q3W Dose of 1000mg/m2 on day 1-14 of each cycle. |
|
| Tislelizumab | Drug | 200mg IV Q3W on day 1 of each cycle. |
|
| 2 years |
| Overall survival (OS) | Defined as the time from initiation of treatment to death from any cause. | 3 years |
| Daping Hospital, Army Medical University | Active, not recruiting | Chongqing | Chongqing Municipality | 400042 | China |
| 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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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C519688 | XELOX |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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