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

NCT ID: NCT05777707

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-29
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PD-1 blockade

Intervention Type: DRUG

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

Albumin paclitaxel

Intervention Type: DRUG

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

Carboplatin/Nedaplatin

Intervention Type: DRUG

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

Interventions

PD-1 blockade

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

Intervention Type: DRUG

Albumin paclitaxel

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

Intervention Type: DRUG

Carboplatin/Nedaplatin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qin li

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qin Li, MD

Role: CONTACT

qinli128003@ccmu.edu.cn

13701288153

Facility Contacts

Qin Li, MD

Role: primary

qinli128003@ccmu.edu.cn

13701288153

Other Identifiers

BeijingHF

Identifier Type: -

Identifier Source: org_study_id