Jinan Central Hospital
Jinan, Shandong, 250000, China
Location contact
Meili Sun, Director, Department of Oncology, MD, PhD
PRINCIPAL_INVESTIGATOR
Yawen Zhen, Associate Director, Department of Oncology
CONTACT
NCT Number: NCT07116577
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Jinan, Shandong, 250000, China
Meili Sun, Director, Department of Oncology, MD, PhD
PRINCIPAL_INVESTIGATOR
Yawen Zhen, Associate Director, Department of Oncology
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to approximately 2 years.
The rates of adverse events.
Contact information is provided by the study sponsor or research team.
Jinan Central Hospital
Other
A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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