Actively Recruiting
Neoadjuvant QL1706 Therapy for ESCC
Led by Shandong Provincial Hospital · Updated on 2025-04-18
32
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg/kg, q3w) in combination with albumin-bound paclitaxel (260 mg/m² on day 1, q3w) plus cisplatin (75 mg/m² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.
CONDITIONS
Official Title
Neoadjuvant QL1706 Therapy for ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate in the study
- Age between 18 and 75 years, male or female
- ECOG performance status of 0 to 1
- Planned surgical treatment after neoadjuvant therapy
- Pathologically diagnosed esophageal squamous cell carcinoma classified as ct1b-ct2n+ or ct3-ct4a any nm0
You will not qualify if you...
- Active or history of autoimmune disease (including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid disorders, vitiligo; controlled childhood asthma without treatment allowed)
- Use of immunosuppressive drugs or systemic/absorbed hormones for immunosuppression within 2 weeks before enrollment
- Severe allergic reaction to other monoclonal antibodies
- Uncontrolled cardiac conditions such as heart failure above NYHA grade 2, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc
- Risk of massive bleeding
- Abnormal coagulation or bleeding tendencies, or on thrombolytic/anticoagulant therapy
- Genetic or acquired bleeding/thrombotic disorders or recent thrombosis within 6 months
- Active infection or fever above 38.5°C during screening
- History or evidence of severe lung disease or impaired lung function
- Congenital or acquired immune deficiency or active hepatitis B or C infection
- Participation in other clinical trials within 4 weeks before first treatment
- Previous or current other malignant tumors
- Receiving other systemic anti-tumor treatments during the study
- Prior PD-1/PD-L1 antibody or immunotherapy
- Live vaccine administration less than 4 weeks before or during the study
- Other serious diseases or conditions that may require combined treatment or affect safety/data collection as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Provincial Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
A
A Lei Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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