NCT04006041

Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Cancer

Status unknown Phase 2 Last updated 26 December 2019

What this trial tests

Phase 2 trial testing Toripalimab in Esophageal Squamous Cell Carcinoma by AJCC V8 Stage in 44 participants. Status unknown.

Timeline

25 June 2019

Primary endpoint
30 June 2020

31 December 2020

Quick facts

Lead sponsor	Jianhua Fu
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	25 June 2019
Primary completion	30 June 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• Toripalimab (TORIPALIMAB) — full drug profile →
• Paclitaxel/cisplatin
• Intensity-modulated radiotherapy
• Esophagectomy

Conditions studied

• Esophageal Squamous Cell Carcinoma by AJCC V8 Stage — all drugs for Esophageal Squamous Cell Carcinoma by AJCC V8 Stage →
• Resectable Esophageal Cancer — all drugs for Resectable Esophageal Cancer →

Sponsor

Jianhua Fu

Who can join

Adults 18 to 70, any sex, with Esophageal Squamous Cell Carcinoma by AJCC V8 Stage or Resectable Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC).

Publications & conference data

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

1. Understanding Esophageal Cancer: The Challenges and Opportunities for the Next Decade.
   Yang J, Liu X, Cao S, Dong X, et al · · 2020 · cited 134× · PMID 33014854 · DOI 10.3389/fonc.2020.01727
2. 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
3. Recent Advances in Combination of Immunotherapy and Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.
   Wang R, Liu S, Chen B, Xi M. · · 2022 · cited 35× · PMID 36291954 · DOI 10.3390/cancers14205168
4. The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer.
   Yang H, Wang K, Wang T, Li M, et al · · 2020 · cited 35× · PMID 32195194 · DOI 10.3389/fonc.2020.00300
5. Immunotherapy for Esophageal Cancer: State-of-the Art in 2021.
   Teixeira Farinha H, Digklia A, Schizas D, Demartines N, et al · · 2022 · cited 33× · PMID 35158822 · DOI 10.3390/cancers14030554
6. A phase II clinical trial of toripalimab combined with neoadjuvant chemoradiotherapy in locally advanced esophageal squamous cell carcinoma (NEOCRTEC1901).
   Chen R, Liu Q, Li Q, Zhu Y, et al · · 2023 · cited 31× · PMID 37560259 · DOI 10.1016/j.eclinm.2023.102118
7. Preoperative pembrolizumab combined with chemoradiotherapy for esophageal squamous cell carcinoma: Trial design.
   Zheng Y, Li C, Yu B, Zhao S, et al · · 2022 · cited 24× · PMID 36003437 · DOI 10.1016/j.xjon.2021.11.003
8. Immune Checkpoint Inhibitors in Esophageal Cancers: are we Finally Finding the Right Path in the Mist?
   Vivaldi C, Catanese S, Massa V, Pecora I, et al · · 2020 · cited 21× · PMID 32121290 · DOI 10.3390/ijms21051658