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

NCT05777707 | Unknown Phase 1

• 1 other identifier: BeijingHF
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma; Neoadjuvant Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pathologic complete remission (PCR)

  4 weeks after surgery

• Major Pathologic Response (MPR)

  4 weeks after surgery

• Overall survival (OS)

  24 months

Study Arms (1)

Neoadjuvant PD-1 Blockade Plus Chemotherapy

EXPERIMENTAL

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; Drug: Albumin paclitaxel; Drug: Carboplatin/Nedaplatin

Interventions

PD-1 blockade DRUG

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

Neoadjuvant PD-1 Blockade Plus Chemotherapy

Albumin paclitaxel DRUG

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

Neoadjuvant PD-1 Blockade Plus Chemotherapy

Carboplatin/Nedaplatin DRUG

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

Neoadjuvant PD-1 Blockade Plus Chemotherapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Qin li

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immune Checkpoint Inhibitors; Carboplatin; nedaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Coordination Complexes; Organic Chemicals

Central Study Contacts

Qin Li, MD

CONTACT

13701288153; qinli128003@ccmu.edu.cn

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: January 30, 2023
• First Posted: March 21, 2023
• Study Start: October 29, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)