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

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05777707

Collaborator

(none)

Enrollment

Location

Arm

50.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Carcinoma Neoadjuvant Immunotherapy	Drug: PD-1 blockade Drug: Albumin paclitaxel Drug: Carboplatin/Nedaplatin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

89 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neoadjuvant PD-1 Blockade Plus Chemotherapy 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.	Drug: PD-1 blockade PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles. Drug: Albumin paclitaxel Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles. Drug: Carboplatin/Nedaplatin Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

Arm

Intervention/Treatment

Experimental: Neoadjuvant PD-1 Blockade Plus Chemotherapy

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.

Drug: PD-1 blockade

PD-1 blockade (Sintilimab/Camrelizumab/Toripalimab/Tislelizumab), 200 mg, IV., every 3 weeks, 2-3 cycles.

Drug: Albumin paclitaxel

Albumin paclitaxel, 300 mg/m2, IV., every 3 weeks, 2-3 cycles.

Drug: Carboplatin/Nedaplatin

Carboplatin/Nedaplatin, area under the curve = 5, IV., every 3 weeks, 2-3 cycles.

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [24 months]
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) [4 weeks after surgery]
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell.
Major Pathologic Response (MPR) [4 weeks after surgery]
MPR was defined as the presence of viable tumor cells≤10% in the resected tumor specimen.
Overall survival (OS) [24 months]
Overall survival was defined as the time from randomization grouping to the time of death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qin li	Beijing	Beijing	China	100029

Sponsors and Collaborators

Beijing Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beijing Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05777707

Other Study ID Numbers:

BeijingHF

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023