Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC

NCT05541445 | Unknown Phase 1

• 1 other identifier: Upper EC program
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Through a prospective, single-center, single-arm, phase Ib/II study, we aim to explore the safety and feasibility of a new treatment mode for upper esophageal cancer, which is that pembrolizumab combined with chemoradiotherapy as neoadjuvant therapy and then followed by radical surgery.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathologic response

  Viable tumor comprised ≤ 10% of resected tumor specimens

  4 months

Secondary Outcomes (5)

• R0 resection rate

  At time of surgery

• Larynx preservation rate

  At time of surgery

• Disease-free survival (DFS)

  24 months

• Local-regional recurrence free survival (LRRFS)

  24 months

• Overall survival (OS)

  24 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Immunotherapy combined with chemotherapy and radiotherapy

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

The subjects first receive induction therapy with pembrolizumab combined with chemotherapy for 6 weeks, and then receive sequential therapy with pembrolizumab combined with concurrent chemoradiotherapy for 6 weeks, and receive surgical treatment within 4-8 weeks after neoadjuvant therapy. For patients whose postoperative pathology is confirmed as PCR (pathological complete response), the patients will be observed with long-time follow-up; If the postoperative pathology is confirmed as non-PCR, pembrolizumab will be administrated until 1 year or disease progression or intolerable toxicity.

Also known as: IO combined therapy

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form before enrollment;
• Be aged 18-80 years old, and be male or female;
• Have potentially upper ESCC (upper edge of tumor ≤ 5cm from esophageal entrance) diagnosed with cT1-3N1-2M0 or cT2-3N0M0 (AJCC 8th);
• Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
• No previous treatments;
• Be eligible for R0 resection before treatment;
• Demonstrate adequate organ function; all screening laboratory tests will be performed within 10 days of treatment initiation;
• Have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication if they are a female subject with childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
• Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. "Newly obtained" is defined as a specimen obtained up to 4 weeks (28 days) before the initiation of treatment on Day 10. Subjects for whom newly obtained samples cannot be provided (e.g., as newly obtained sample is inaccessible or due to subject safety concerns) may submit an archived specimen, but only with the agreement of the sponsor;
• \. Be expected to survive \>6 months; 12. Join the clinical study on a completely voluntary basis, demonstrate good adherence, and cooperate with the follow-up assessments for safety and survival

You may not qualify if:

• Have undergone any previous therapy (e.g., an operation, radiotherapy, immunotherapy, or chemotherapy) for ESCC;
• Have a history of other malignant tumor;
• Be ineligible or have a contraindication for esophagectomy;
• Have a history of other anti-PD-1/PD-L1 therapies, or have a known history of an allergy to macromolecular protein preparations or any component of PD-1;
• Have a diagnosis of immunodeficiency or have received chronic systemic steroid therapy (in doses \>10 mg daily of a prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of the study drug;
• Have an active autoimmune disease that required systemic treatment in the past 2 years (e.g., the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs);
• Have poorly controlled cardiac symptoms or cardiac diseases;
• Have a history or evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

pembrolizumab

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

Study Officials

• Jie He, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Li, MD

CONTACT

+8613831120879; liyongdoctor@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)