mCRC
Conditions
Brief summary
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.
Interventions
RADIATIONPalliative radiotherapy
Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
DRUGTAS-102
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).
DRUGBevacizumab
7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Sponsors
Jinan Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 75 years . * Histologically confirmed unresectable colorectal adenocarcinoma. * Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance. * Documented KRAS and BRAF mutation status (mutant or wild-type) must be available. * Palliative radiotherapy targeting primary or metastatic lesions is planned. * At least one measurable lesion per RECIST v1.1 exists. * ECOG score of 0-1 and life expectancy ≥12 weeks. * Adequate bone marrow, hepatic, and renal function must be demonstrated. * Fertile patients commit to using effective contraception during and for 6 months post-treatment.
Exclusion criteria
* History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment. * Radiation or systemic anticancer therapy within 14 days prior to first study treatment. * Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae. * Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis. * Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial). * Uncontrolled cardiovascular/cerebrovascular diseases. * Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | approximately 4 months after the last subject participating in | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | approximately 12 months after the last subject participating in | the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects. |
| OS | approximately 12 months after the last subject participating in | The time from the starting date of study drug to the date of death due to any cause. |
| DCR | approximately 4 months after the last subject participating in | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects |
| Safety (adverse event) | Up to approximately 2 years. | The rates of adverse events. |
Countries
China
Contacts
Primary ContactYawen Zhen, Associate Director, Department of Oncology
Outcome results
None listed