RecruitingPhase 2NCT06489197

AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients

Ivonescimab(AK112) Combined With Chemotherapy as the First-line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Single Arm , Phase II Trial


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

Nov 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm,phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled. The research will be conducted in two stages. In the first part, 6 patients were enrolled in the group. After the last subject in the group completed at least 21 days of observation after the first medication, the researchers will conduct a preliminary safety and effectiveness assessment. If the safety and tolerability are good, it will enter the second expansion part till the study enrolled 30 patients. Patients who met the inclusion criteria were treated with AK112 (20mg/kg, intravenous infusion, d1, Q3W) in combination with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment — a drug called AK112 (which blocks two proteins that help cancer evade the immune system) plus chemotherapy — as a first-line treatment for people with advanced esophageal squamous cell carcinoma (a type of throat/esophagus cancer) that cannot be surgically removed. **You may be eligible if...** - You are 18 to 75 years old with confirmed advanced or metastatic esophageal squamous cell carcinoma - You have not received any prior systemic treatment for this cancer - You have at least one measurable tumor - Your overall health is good enough for chemotherapy (ECOG 0 or 1) - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have had prior immunotherapy or systemic cancer treatment - You have brain metastases or serious infections - You have significant heart, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIvonescimab combined with albumin paclitaxel and cisplatin

Ivonescimab (20mg/kg, intravenous infusion, d1, Q3W) combined with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months.


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06489197


Related Trials