NCT04821765

Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer

Completed Phase 2 Last updated 30 May 2025

What this trial tests

Phase 2 trial testing PD-1 antibody in Esophagus Cancer in 35 participants. Completed in 31 December 2024.

Timeline

1 October 2020

Primary endpoint
30 June 2023

31 December 2024

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 October 2020
Primary completion	30 June 2023
Estimated completion	31 December 2024
Sites	2 locations across China

Drugs / interventions tested

• PD-1 antibody — full drug profile →
• Chemoradiation — full drug profile →
• Albumin-Bound Paclitaxel — full drug profile →
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Esophagus Cancer — all drugs for Esophagus Cancer →
• Chemoradiotherapy — all drugs for Chemoradiotherapy →
• Oligometastatic Disease — all drugs for Oligometastatic Disease →
• Immunotherapy — all drugs for Immunotherapy →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, any sex, with Esophagus Cancer or Chemoradiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chemoradiotherapy（CRT） is the main treatment for esophageal cancer patients with recurrent desease，and checkpoint blockade (PD-1) have been shown to be effective in advanced esophageal cancer. Therefore, PD-1 combined with chemoradiotherapy （CRT）may further improve the efficacy and become a new method for the treatment of esophageal cancer.This study intends to conduct a single-arm, prospective clinical study, aiming to evaluate the safety and efficacy of PD-1 combined with chemoradiotherapy(CRT) in patients with oligometastatic esophageal squamous cell carcinoma.

Publications & conference data

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

1. Mechanisms of radiotherapy resistance and radiosensitization strategies for esophageal squamous cell carcinoma.
   An L, Li M, Jia Q. · · 2023 · cited 129× · PMID 37598158 · DOI 10.1186/s12943-023-01839-2
2. Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
   Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5
3. Immunotherapy for Squamous Esophageal Cancer: A Review.
   Petrillo A, Smyth EC. · · 2022 · cited 22× · PMID 35743646 · DOI 10.3390/jpm12060862
4. The Role of Radiomics in the Era of Immune Checkpoint Inhibitors: A New Protagonist in the Jungle of Response Criteria.
   Castello A, Castellani M, Florimonte L, Urso L, et al · · 2022 · cited 20× · PMID 35330068 · DOI 10.3390/jcm11061740
5. Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions.
   Jiang M, Hu Y, Lin G, Chen C, et al · · 2023 · cited 18× · PMID 37325652 · DOI 10.3389/fimmu.2023.1177085
6. Efficacy and safety of radiotherapy/chemoradiotherapy combined with immune checkpoint inhibitors for locally advanced stages of esophageal cancer: A systematic review and meta-analysis.
   Wu J, Deng R, Ni T, Zhong Q, et al · · 2022 · cited 15× · PMID 35992797 · DOI 10.3389/fonc.2022.887525
7. Targeting esophageal carcinoma: molecular mechanisms and clinical studies.
   Wang W, Ye L, Li H, Mao W, et al · · 2024 · cited 7× · PMID 39415846 · DOI 10.1002/mco2.782
8. Opportunities and challenges in combining immunotherapy and radiotherapy in esophageal cancer.
   Zhang X, Cai X, Yan C. · · 2023 · cited 6× · PMID 37985502 · DOI 10.1007/s00432-023-05499-z