??Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:The treatment regimen consists of:
Induction therapy with iparomlimab toripalimab (QL1706) combined with nab-paclitaxel (albumin-bound paclitaxel).
Nab-paclitaxel (albumin-bound pac
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study, demonstrates good compliance, is able to cooperate with the trial requirements for observation and follow-up, and has signed the informed consent form. 2. Pathologically confirmed esophageal squamous cell carcinoma, with clinical staging of locally advanced or metastatic esophageal cancer, and eligible to receive specialized anti-tumor treatment. 3. The subject is not suitable for radical surgical treatment. 4. According to RECIST 1.1, the patient has at least one measurable lesion (>=1 cm in diameter by CT scan or >=2 cm by other imaging methods). 5. ECOG performance status =3,000/µL, absolute neutrophil count (ANC) >=1,500/µL, platelets >=100,000/µL, hemoglobin >=9.0 g/dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =60% as assessed by Doppler echocardiography. 10. Female: Contraception during treatment and for 6 months after treatment completion, and not breastfeeding. Male: Contraception during treatment and for 6 months after treatment completion.
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant, breastfeeding, or of childbearing potential without contraception; 2. Patients with severe acute infections, suppurative or chronic infections, or non-healing wounds; 3. Patients with esophageal perforation (esophagotracheal fistula or those at risk of developing one); 4. Patients who have previously received systemic antitumor therapy for unresectable, locally advanced, or metastatic esophageal cancer; 5. Patients with abnormal coagulation function, bleeding tendency (e.g., active gastrointestinal ulcers), or those undergoing thrombolytic or anticoagulant therapy; 6. Patients with severe heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction within the past 6 months, severe valvular heart disease, or refractory hypertension; 7. Patients with poorly controlled neurological or psychiatric disorders, poor compliance, or inability to cooperate and report treatment responses; 8. Patients with severe liver cirrhosis or severe renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Quality of Life Score;Adverse Event; | — |
Countries
China
Contacts
Public ContactLiu Fang
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed