A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-08

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

NCT06173986

Esophageal Squamous Cell Carcinoma Unresectable Locally Advanced Esophageal Cancer

RECRUITING PHASE1/PHASE2

Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer

NCT07015489

ESCC

COMPLETED PHASE2

Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: a Single Center, Prospective, Open, One Arm Exploratory Clinical Study

NCT05028231

Esophageal Squamous Cell Carcinoma Neoadjuvant Therapies

UNKNOWN

Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

NCT06888531

Esophageal Malignant Neoplasm Primary

ACTIVE_NOT_RECRUITING PHASE2

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06907602

Locally Advanced Esophageal Squamous Cell Carcinoma

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this single-center, open-label, non-inferior, randomized controlled, interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoadjuvant Therapy Esophageal Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

neoadjuvant immunotherapy plus chemotherapy and anlotinib

Group Type EXPERIMENTAL

Thoracic radiotherapy

Intervention Type RADIATION

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period

Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles

Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles

Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Thoracic radiotherapy RT once daily (from cycle 1 \[C1D1\], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/week)

neoadjuvant immunotherapy combined with concurrent chemoradiotherapy

Group Type EXPERIMENTAL

anlotinib

Intervention Type DRUG

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period

Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles

Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles

Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anlotinib

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period

Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles

Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles

Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles

Intervention Type DRUG

Thoracic radiotherapy

Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period

Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles

Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles

Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles

Thoracic radiotherapy RT once daily (from cycle 1 \[C1D1\], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/week)

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

radiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No