Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT06802666
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2025-01-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
Detailed Description:
Study includes a screening period (from the time the participant signs the informed consent form until the first treatment, not exceeding 21 days), treatment period (including full neoadjuvant therapy, surgery, and postoperative adjuvant treatment), and follow-up period (including safety follow-up and survival follow-up ).
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W.The surgery was performed 1 week after the end of neoadjuvant therapy.After surgery, the investigator conducts a pathological assessment of the surgical specimen for response evaluation. Then, there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W.The surgery was performed 1 week after the end of neoadjuvant therapy.After surgery, the investigator conducts a pathological assessment of the surgical specimen for response evaluation. Then, there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: