Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma

Esophageal Carcinoma Clinical Trial

Official title:

Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777707
• Other study ID #: BeijingHF
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 29, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Beijing Friendship Hospital
• Contact: Qin Li, MD
• Phone: 13701288153
• Email: qinli128003[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 89
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. age = 18 years and =89 years;

2. pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;

3. clinical stage II-IVA;

4. adequate organ function;

5. no previous chemotherapy or radiotherapy;

6. voluntarily signed informed consent.

Exclusion Criteria:

1. the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;

2. patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;

3. patients undergoing systemic corticosteroid or other immunosuppressive treatments;

4. patients with a history of allergy to the components of this test drug.

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Neoadjuvant Immunotherapy

Intervention

Drug:
• PD-1 blockade
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
• Albumin paclitaxel
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
• Carboplatin/Nedaplatin
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

Locations

Country	Name	City	State
China	Qin li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.	24 months
Secondary	Pathologic complete remission (PCR)	Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.	4 weeks after surgery
Secondary	Major Pathologic Response (MPR)	MPR was defined as the presence of viable tumor cells=10% in the resected tumor specimen.	4 weeks after surgery
Secondary	Overall survival (OS)	Overall survival was defined as the time from randomization grouping to the time of death due to any cause.	24 months