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

Primary Purpose

Esophageal Carcinoma, Neoadjuvant Immunotherapy

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PD-1 blockade
Albumin paclitaxel
Carboplatin/Nedaplatin
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age ≥ 18 years and ≤89 years; pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma; clinical stage II-IVA; adequate organ function; no previous chemotherapy or radiotherapy; voluntarily signed informed consent. Exclusion Criteria: the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer; patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV; patients undergoing systemic corticosteroid or other immunosuppressive treatments; patients with a history of allergy to the components of this test drug.

Sites / Locations

  • Qin liRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant PD-1 Blockade Plus Chemotherapy

Arm Description

PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles; Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles; Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.
Major Pathologic Response (MPR)
MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.
Overall survival (OS)
Overall survival was defined as the time from randomization grouping to the time of death due to any cause.

Full Information

First Posted
January 30, 2023
Last Updated
March 8, 2023
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05777707
Brief Title
Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma
Official Title
Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Locally Advanced Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma, Neoadjuvant Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant PD-1 Blockade Plus Chemotherapy
Arm Type
Experimental
Arm Description
PD-1 blockade, 200 mg, IV., every 3 weeks, 2-3 cycles; Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles; Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Intervention Type
Drug
Intervention Name(s)
PD-1 blockade
Intervention Description
PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.
Intervention Type
Drug
Intervention Name(s)
Albumin paclitaxel
Intervention Description
Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin/Nedaplatin
Intervention Description
Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.
Primary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
Disease-free survival was defined as the time from randomization until the first documented disease recurrence or death due to any cause.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pathologic complete remission (PCR)
Description
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.
Time Frame
4 weeks after surgery
Title
Major Pathologic Response (MPR)
Description
MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.
Time Frame
4 weeks after surgery
Title
Overall survival (OS)
Description
Overall survival was defined as the time from randomization grouping to the time of death due to any cause.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 18 years and ≤89 years; pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma; clinical stage II-IVA; adequate organ function; no previous chemotherapy or radiotherapy; voluntarily signed informed consent. Exclusion Criteria: the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer; patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV; patients undergoing systemic corticosteroid or other immunosuppressive treatments; patients with a history of allergy to the components of this test drug.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Li, MD
Phone
13701288153
Email
qinli128003@ccmu.edu.cn
Facility Information:
Facility Name
Qin li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Li, MD
Phone
13701288153
Email
qinli128003@ccmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

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

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