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

NCT06354530 | Recruiting Phase 2

• 1 other identifier: 2023 (315)
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoadjuvant Therapy; Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Pathological complete response (pCR), Major pathological response (MPR)

  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)

  Major pathological response (MPR)

  Up to approximately 15 weeks after randomization

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to approximately 15 weeks after randomization

• 3-year disease free survival

  From date of randomization to approximately 3 years after date of resection

• R0 excision rate

  Up to approximately 15 weeks after randomization

• 3-year overall survival

  From date of randomization to approximately 3 years after date of resection

Study Arms (2)

neoadjuvant immunotherapy plus chemotherapy and anlotinib

EXPERIMENTAL

neoadjuvant immunotherapy plus chemotherapy and anlotinib

Radiation: Thoracic radiotherapy

neoadjuvant immunotherapy combined with concurrent chemoradiotherapy

EXPERIMENTAL

neoadjuvant immunotherapy combined with concurrent chemoradiotherapy

Drug: anlotinib

Interventions

anlotinib 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

neoadjuvant immunotherapy combined with concurrent chemoradiotherapy

Thoracic radiotherapy 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)

Also known as: radiotherapy

neoadjuvant immunotherapy plus chemotherapy and anlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Army Medical Center of PLA: lead

Study Sites (1)

Army Medical Center of PLA

Chongqing, None Selected, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

anlotinib; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jingjing Wang

  Army Medical Center of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengxia Li

CONTACT

86-18580408265; mengxia.li@outlook.com

Xiao Yang

CONTACT

86-19923257675; yangxiao625@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Cancer Center, Army Medical Center of PLA

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 9, 2024
• Study Start: March 8, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)