Neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma
Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC
This study is testing two different treatment plans for people with advanced esophageal cancer to see which one works better and is safer before surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Army Medical Center of PLA Government |
| Drugs / interventions | anlotinib, chemotherapy, immunotherapy |
| Locations | 1 site (Chongqing, None Selected) |
| Trial ID | NCT06354530 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to compare the safety and efficacy of two treatment regimens for patients with locally advanced esophageal squamous cell carcinoma. One group will receive neoadjuvant immunotherapy combined with chemotherapy and anlotinib, while the other will receive immunotherapy with concurrent chemoradiotherapy. The study is designed as a single-center, open-label, randomized controlled trial to determine the optimal preoperative treatment approach. The primary focus is on evaluating the safety and effectiveness of these therapies in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with surgically resectable locally advanced esophageal squamous cell carcinoma who meet specific health criteria.
Not a fit: Patients with previous systemic antitumor treatment or those with serious complications or major diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective neoadjuvant treatment option for patients with locally advanced esophageal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promise with neoadjuvant immunotherapy approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology * Patients who can take anlotinib capsules orally * No previous systematic antitumor treatment * ECOG PS 0-1 * The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10\^9 / L; platelet≥80×10\^9 / L; hemoglobin≥80×10\^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal * No incurable serious complications or other major diseases * The thoracic surgeon judges that the operation can be tolerated * Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy * The subjects volunteered to join the study, signed informed consent, had good compliance and cooperated with follow-up Exclusion Criteria: * BMI\<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight) * Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication * Patients with significant feeding obstruction unable to take oral anlotinib * Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO) * Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine * A history of active autoimmune diseases and autoimmune diseases * A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation * The subject had cardiovascular clinical symptoms or disease that were not well controlled * Patients with active hepatitis B or hepatitis C and active pulmonary tuberculosis * Severe infection (CTCAE\> 2) occurred within 4 weeks prior to initial use of study drug, such as severe pneumonia, bacteremia, infection requiring hospitalization; baseline chest imaging indicated active lung inflammation, symptoms and signs of infection within 2 weeks prior to initial use of study drug or the need for oral or intravenous antibiotics, except for prophylactic antibiotics * Major surgery (except diagnostic surgery) within 28 days prior to treatment, or is expected to undergo major surgery during the study * Any other malignancy had been diagnosed within 5 years prior to the first use of study drug, except for nausea tumors with low risk and mortality (5-year survival\> 90%), such as adequately treated basal or squamous cell skin carcinoma or carcinoma of the cervix * Female patients during pregnancy or lactation and who were refused or unable to use contraception * At the discretion of the investigator, the subject had other factors that could contribute to his forced termination
Where this trial is running
Chongqing, None Selected
- Army Medical Center of PLA — Chongqing, None Selected, China (Recruiting)
Study contacts
- Principal investigator: Jingjing Wang — Army Medical Center of PLA
- Study coordinator: Mengxia Li
- Email: mengxia.li@outlook.com
- Phone: 86-18580408265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.