NCT04666090

A Prospective, One-arm, Single-center, Phase Ⅱ Clinical Study of Carrelizumab Combined With Chemotherapy and Antiangiogenic Drugs in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

Active, enrolled Phase 2 Last updated 12 May 2025

What this trial tests

Phase 2 trial testing Carillizumab in Esophageal Squamous Cell Carcinoma in 42 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 November 2020

Primary endpoint
31 December 2022

1 November 2030

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	23 November 2020
Primary completion	31 December 2022
Estimated completion	1 November 2030
Sites	1 location across China

Drugs / interventions tested

• Carillizumab — full drug profile →
• Esophagectomy
• Samples — full drug profile →

Conditions studied

• Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinoma or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pathological Complete Response (PCR)
  Time frame: 1 month after surgery
  No residual invasive tumor cells were found in the pathological examination of resected specimens.

Sponsor's own description

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased.

For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients.

According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that Carrillizumab provided higher overall response rate for advanced esophageal cancer.

However, in patients with locally advanced esophageal cancer, the efficacy of Carrillizumab combined with chemotherapy and apatinib for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of Carrillizumab combined with chemotherapy and antiangiogenic drugs in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoadjuvant immunotherapy for resectable esophageal cancer: A review.
   Li Q, Liu T, Ding Z. · · 2022 · cited 43× · PMID 36569908 · DOI 10.3389/fimmu.2022.1051841
2. Perioperative immunotherapy for esophageal squamous cell carcinoma: Now and future.
   Liu Y. · · 2023 · cited 16× · PMID 37753366 · DOI 10.3748/wjg.v29.i34.5020
3. Immunotherapy in the neoadjuvant treatment of gastrointestinal tumors: is the time ripe?
   Gervaso L, Ciardiello D, Oliveira RA, Borghesani M, et al · · 2024 · cited 12× · PMID 38782539 · DOI 10.1136/jitc-2023-008027
4. Immunotherapy during the Immediate Perioperative Period: A Promising Approach against Metastatic Disease.
   Sandbank E, Eckerling A, Margalit A, Sorski L, et al · · 2023 · cited 10× · PMID 37623021 · DOI 10.3390/curroncol30080540
5. From tumor microenvironment to emerging biomarkers: the reshaping of the esophageal squamous cell carcinoma tumor microenvironment by neoadjuvant chemotherapy combined with immunotherapy.
   Qiu Z, Li Z, Liu X, Zhang R, et al · · 2024 · cited 6× · PMID 39703499 · DOI 10.3389/fimmu.2024.1478922
6. Camrelizumab, chemotherapy and apatinib in the neoadjuvant treatment of resectable oesophageal squamous cell carcinoma: a single-arm phase 2 trial.
   Wu Z, Wu C, Zhao J, Wu C, et al · · 2024 · cited 6× · PMID 38618203 · DOI 10.1016/j.eclinm.2024.102579