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
This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above.
This pilot phase I trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (PD-1) inhibitors in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. All will take part at Jiangsu Cancer Hospital.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High- and Low-dose radiotherapy combined with immunotherapy. | Experimental | All eligible patients will receive high-dose radiotherapy, followed by low-dose radiotherapy combined with PD-1 inhibitor therapy starting within 7 days after completion. The single dose of high-dose radiotherapy will be 6-8 Gy for 3-7 consecutive exposures, and the single dose of low-dose radiotherapy will be 0.5-1.4 Gy for 3-7 consecutive exposures.The PD-1 inhibitor (Zimberelimab) will be administered at the dose recommended in the specification every 3 weeks until disease progression, unacceptable toxicity, and withdrawal of informed consent by the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation: High- and Low-dose radiotherapy | Radiation | High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of patients showing complete or partial response of low-dose radiotherapy lesions and other metastatic lesions assessed by RECIST v1.1 | 1,3,6, and 12 months after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From the start of treatment to the date of progression or death | 12 months |
| Overall survival (OS) | the time from the start of treatment to death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity) | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxuan Ding | Contact | 18951590901 | dyxoo99@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD-1 Inhibitors | Drug | Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy. |
|
| 12 months |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |