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

Phase 1

Recruiting

• Conditions: Esophageal Carcinoma; Neoadjuvant Immunotherapy
• Interventions: Drug: PD-1 blockade; Drug: Albumin paclitaxel; Drug: Carboplatin/Nedaplatin

• Registration Number: NCT05777707
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-29
• Status Verified: 2023-01
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant PD-1 Blockade Plus Chemotherapy	PD-1 blockade	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.
Neoadjuvant PD-1 Blockade Plus Chemotherapy	Carboplatin/Nedaplatin	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.
Neoadjuvant PD-1 Blockade Plus Chemotherapy	Albumin paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Qin li; 🇨🇳 Beijing, Beijing, China