Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

NCT ID: NCT05302011

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-06-30

Brief Summary

This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients

Detailed Description

The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of neoadjuvant pembrolizumab plus chemotherapy (carboplatin, paclitaxel).

Secondary objectives are:

To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess toxicities of neoadjuvant pembrolizumab plus chemotherapy To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Pembrolizumab Plus Chemotherapy

Neoadjuvant Pembrolizumab Plus Chemotherapy

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab 200mg i.v. day 1-22-43-64

Carboplatin or Cisplatin

Intervention Type: DRUG

Carboplatin Area Under the Curve(AUC) = 4-5 i.v. day 1-22-43-64 or Cisplatin 75mg/m2 i.v. day 1-22-43-64

Docetaxel

Intervention Type: DRUG

75mg/m2 i.v. day 1-22-43-64

Interventions

Pembrolizumab

Pembrolizumab 200mg i.v. day 1-22-43-64

Intervention Type: DRUG

Carboplatin or Cisplatin

Carboplatin Area Under the Curve(AUC) = 4-5 i.v. day 1-22-43-64 or Cisplatin 75mg/m2 i.v. day 1-22-43-64

Intervention Type: DRUG

Docetaxel

75mg/m2 i.v. day 1-22-43-64

Intervention Type: DRUG

Other Intervention Names

chemotherapy; chemotherapy

Eligibility Criteria

Inclusion Criteria

• Histologically proven squamous cell carcinoma of the esophagus.
• Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),Positron Emission Tomography/Computed Tomography (PET/CT), Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.
• Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator.
• 18≤Age.
• Tumor does not involve gastro-esophageal junction.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematological, renal and hepatic functions defined as:

neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance (Cockcroft) ≥60 ml/min

• Written, voluntary informed consent

Exclusion Criteria

• Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
• T1, T2 tumors or in situ carcinoma.
• metastatic oesophageal cancer.
• Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
• Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
• Pulmonary fibrosis and/or severely impaired lung function precluding major surgery.
• Pre-existing motor or sensory neurotoxicity greater than World Health Organization (WHO) grade 1.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Dementia or altered mental status that would prohibit the understanding and giving of informed consent
• Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
• Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
• Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency or human immunodeficiency virus (HIV).
• Patients with prior allogeneic stem cell or solid organ transplantation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Li, MD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Keypoint-1

Identifier Type: -

Identifier Source: org_study_id