Neoadjuvant therapy for esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to enroll 32 patients with locally advanced resectable esophageal squamous cell carcinoma to evaluate the effectiveness of a treatment regimen combining Iparomlimab and Tuvonralimab (QL1706) with chemotherapy. Patients will receive intravenous infusions of QL1706 alongside either albumin-bound paclitaxel and cisplatin or carboplatin for three cycles, followed by surgical resection 3-6 weeks post-treatment. The study will analyze changes in the tumor immune microenvironment and monitor circulating tumor DNA at various time points. The primary goal is to assess the pathological complete response rate, with secondary endpoints focusing on major pathological response and adverse reactions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent form to voluntarily join this study;
2. Age 18-75 years old, male or female;
3. ECOG PS 0-1;
4. Planned surgical treatment after completion of neoadjuvant therapy;
5. Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0

Exclusion Criteria:

1. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject suffers from vitiligo; asthma has been completely relieved in childhood and does not need any intervention after adulthood can be included, but asthma that needs bronchodilators for medical intervention cannot be included);
2. The subjects are using immunosuppressive agents or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment;
3. Severe allergic reaction to other monoclonal antibodies;
4. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) qtc\>450ms (male); Qtc\>470ms (female);
5. Patients at risk of massive bleeding
6. Abnormal coagulation function (inr\>1.5 or pt\>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
7. Genetic or known to exist Acquired hemorrhage and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or arteriovenous thrombosis events in recent 6 months (until the first use of shr-1210);
8. Subjects with active infection or fever of unknown origin\>38.5 degrees during screening and before the first administration;
9. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
10. Subjects with congenital or acquired immune deficiency (such as HIV infected), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);
11. Those who have used other drugs in clinical trials within 4 weeks before the first medication;
12. The subjects had previously or simultaneously suffered from other malignant tumors;
13. Subjects may receive other systemic anti-tumor treatment during the study period;
14. The subjects had previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L1;
15. Live vaccines were administered less than 4 weeks before the study or during the study period;
16. According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.

Where it's running

• Shandong Provincial Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: A Lei Feng
• Email: 370100668@qq.com
• Phone: +8613402214659

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.