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This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative radiotherapy | Radiation | Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. | approximately 4 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects. | approximately 12 months after the last subject participating in |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yawen Zhen, Associate Director, Department of Oncology | Contact | +86 150 2001 0760 | my123454321@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Meili Sun, Director, Department of Oncology, MD, PhD, | Jinan Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Iparomlimab and tuvonralimab | Drug | 5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days). |
|
| TAS-102 | Drug | 35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks). |
|
| Bevacizumab | Drug | 7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. |
|
The time from the starting date of study drug to the date of death due to any cause.
| approximately 12 months after the last subject participating in |
| DCR | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects | approximately 4 months after the last subject participating in |
| Safety (adverse event) | The rates of adverse events. | Up to approximately 2 years. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |