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

April 3, 2024 updated by: Mengxia Li, Army Medical Center of PLA

Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • None Selected
      • Chongqing, None Selected, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neoadjuvant immunotherapy plus chemotherapy and anlotinib
Radiation: 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)

Other Names:
  • radiotherapy
Experimental: neoadjuvant immunotherapy combined with concurrent chemoradiotherapy
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR), Major pathological response (MPR)
Time Frame: Up to approximately 15 weeks after randomization
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes
Up to approximately 15 weeks after randomization
Major pathological response (MPR)
Time Frame: Up to approximately 15 weeks after randomization
Major pathological response (MPR)
Up to approximately 15 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to approximately 15 weeks after randomization
Objective response rate (ORR)
Up to approximately 15 weeks after randomization
3-year disease free survival
Time Frame: From date of randomization to approximately 3 years after date of resection
3-year disease free survival
From date of randomization to approximately 3 years after date of resection
R0 excision rate
Time Frame: Up to approximately 15 weeks after randomization
R0 excision rate
Up to approximately 15 weeks after randomization
3-year overall survival
Time Frame: From date of randomization to approximately 3 years after date of resection
3-year overall survival
From date of randomization to approximately 3 years after date of resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Army Medical Center of PLA

Investigators

  • Principal Investigator: Jingjing Wang, Army Medical Center of PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 (315)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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