Neoadjuvant therapy for esophageal cancer

A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

This study is testing a new combination of treatments for patients with advanced esophageal cancer to see if it can help shrink tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Provincial Hospital (Government)
• Drugs / interventions: immunotherapy, radiation, prednisone, Iparomlimab, Tuvonralimab, chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06908382 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with resectable esophageal squamous cell carcinoma and an ECOG performance status of 0-1.

Not a fit: Patients with active autoimmune diseases or those requiring immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival for patients with esophageal squamous cell carcinoma.

How similar studies have performed: While similar approaches have been explored, this specific combination of therapies in the neoadjuvant setting for esophageal cancer is relatively novel.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: A Lei Feng

Conditions Locally Advanced Resectable Esophageal Squamous Cell Carcinoma