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

NCT04821765 | Completed Phase 2

• 1 other identifier: NCC2749
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Esophagus Cancer; Chemoradiotherapy; Oligometastatic Disease; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Locoregional control rate

  3 year

Secondary Outcomes (6)

• Number of participants with acute toxicities

  10 week, from the start of treatment to 1 month after chemoradiotherapy

• Tumor response rate

  2-3 months

• Progression free survival

  1 year, 2 year, 3 year

• Overall survival

  1 year, 2 year, 3 year

• Objective response rate

  5.5 week

Study Arms (1)

Chemoradiotherapy Combined With PD-1 Antibody

EXPERIMENTAL

The arm received chemoradiotherapy, 50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week) to recurrent sites combined with chemotherapy（Cisplatin 75 mg/m2/day 1, and albumin paclitaxel 150 mg/m2/day 1 , every 3 weeks, 2 cycles ).PD-1 antibody (Tislelizumab) was performed simultaneously with concurrent chemoradiotherapy (Triprizumab 200mg，d1，every 3 weeks，2 cycles). After completion of chemoradiotherapy, PD-1 antibody was given continuously with 2-4 cycles of chemotherapy (the same regimen with concurrent chemotherapy) until 1 year or desease progression.

Drug: PD-1 antibody; Radiation: Chemoradiation; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

Interventions

PD-1 antibody DRUG

200mg, d1, q3W

Chemoradiotherapy Combined With PD-1 Antibody

Chemoradiation RADIATION

50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week

Chemoradiotherapy Combined With PD-1 Antibody

Albumin-Bound Paclitaxel DRUG

150mg/m2, d1, q3W

Chemoradiotherapy Combined With PD-1 Antibody

Cisplatin DRUG

75mg/m2, d1, q3W

Chemoradiotherapy Combined With PD-1 Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years；
• Esophageal squamous cell carcinomas；
• After radical treatment including surgery or definitive chemoradiotherapy
• Definition of oligometastases：≤3 metastases, including tumor beds and recurrent anastomotic sites；regional lymph node is defined as one metastatic site（AJCC8th, supraclavicular, mediastinal, abdominal）；metastases lesion in liver, lung, bone and brain is no more than 1.
• Karnofsky performance status(KPS)≥ 70；
• No immunotherapy were performed after recurrence；
• a white-cell count of at least 3500G/L, a hemoglobin concentration of at least 100 g/L, a platelet count of at least 100,000/lL, aspartate aminotransferase and alanine aminotransferase levels of within 1.5 times the upper limit of normal, a serum bilirubin level of 1.5 mg/dL or less, a creatinine level of 1.1 mg/dL or less;
• Hepatitis virus indicators: normal or hepatitis virus DNA titer less than 500 at the same time in an infectious disease hospital, and with the consent of the doctor can be treated；

You may not qualify if:

• Pregnancy, possible pregnancy, or breast-feeding;
• Psychological, family, social and other factors lead to uninformed consent;
• An esophageal mediastinal fistula and/or an esophageal tracheal fistula prior to treatment;
• Serious complications such as ischemic heart disease, arrhythmias, or other types of heart disease requiring treatment; liver cirrhosis; interstitial pneumonia or pulmonary fibrosis; active gastrointestinal bleeding; mental disorders being treated with antipsychoticagents or requiring treatment;
• Controlled diabetes mellitus;
• A history of autoimmune disease, autoimmune disease (such as colitis, hepatitis, hyperthyroidism, including but not limited to these disease or syndrome) and a history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or have a history of organ transplantation and the history of allogeneic bone marrow transplantation;
• A history of interstitial lung disease and a history of non-infectious pneumonia;
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 Copies /mL), hepatitis C ;(positive HCV antibody and HCV-RNA above the detection threshold of the assay）
• Any situation that is unstable or may compromise patient safety and compliance ;
• Active infections, such as active tuberculosis, are present;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, Beijing Municipality, 100021, China

Location

Department 4th of Radiation Oncology, Anyang Cancer Hospital

Anyang, Henan, 455001, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

spartalizumab; Chemoradiotherapy; Albumin-Bound Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 30, 2021
• Study Start: October 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)