Neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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

• Camrelizumab, chemotherapy and Ivarmacitinib before surgery for resectable esophageal squamous cell carcinoma

  This trial tests whether giving camrelizumab with chemotherapy and the JAK inhibitor Ivarmacitinib before surgery can improve outcomes for patients with locally advanced esophageal squamous cell carcinoma that can be removed by operation.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, China · NCT07505186

• Envafolimab with albumin-bound paclitaxel and carboplatin before surgery for resectable locally advanced esophageal squamous cell carcinoma

  This study tests whether adding envafolimab to albumin-bound paclitaxel and carboplatin before surgery helps people with resectable locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07266493

• Ivonescimab plus chemotherapy before surgery for resectable esophageal squamous cell cancer

  This study tests whether giving Ivonescimab together with chemotherapy before esophageal cancer surgery helps patients see better outcomes than surgery alone.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07244978

• Combination of Anlotinib and TQB2450 for Esophageal Cancer Treatment

  This study is testing if combining two medications, Anlotinib and TQB2450, can help people with esophageal cancer stay cancer-free after surgery.

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• Zemetostat plus Anlotinib for SWI/SNF-deficient Head and Neck Soft Tissue Sarcoma

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  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07917949

• Pucotenlimab and Anlotinib with Chemo Before Surgery for Early-Stage Triple-Negative Breast Cancer

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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.