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Esophagus CancerPhase 2NCT04821765

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

A Phase 2 study testing PD-1 antibody, Chemoradiation and Albumin-Bound Paclitaxel in people with Esophagus Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PD-1 antibody, Chemoradiation and Albumin-Bound Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesChina
Study dates
1 Oct 2020to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • •≥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；

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Department 4th of Radiation Oncology, Anyang Cancer Hospital

    Anyang, Henan, 455001

  • 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

Other trials in China

About this study

Official title: A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma

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.

Being tested
PD-1 antibody, Chemoradiation, Albumin-Bound Paclitaxel, Cisplatin
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1 antibodyDrug

    200mg, d1, q3W

  • ChemoradiationRadiation

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

  • Albumin-Bound PaclitaxelDrug

    150mg/m2, d1, q3W

  • CisplatinDrug

    75mg/m2, d1, q3W

Study groups in NCT04821765
Study groupRoleWhat they receive
Chemoradiotherapy Combined With PD-1 AntibodyExperimentalThe 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.
Receives: Drug: PD-1 antibody; Radiation: Chemoradiation; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Locoregional control rate

    Measured: 3 year

Secondary outcomes (6)

  1. Number of participants with acute toxicities

    Acute toxicities are evaluated by NCI-CTC version 5.0

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

  2. Tumor response rate

    Measured: 2-3 months

  3. Progression free survival

    Measured: 1 year, 2 year, 3 year

  4. Overall survival

    Measured: 1 year, 2 year, 3 year

  5. Objective response rate

    Objective Response Rate are evaluated by RECIST 1.1

    Measured: 5.5 week

  6. Radiomics analysis

    Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.

    Measured: 1 year, 2 year, 3 year, 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2021
  2. Study start1 Oct 2020
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821765
Sponsor's protocol ID
NCC2749
Status last verified
May 2025
First submitted
15 Mar 2021
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 antibody, Chemoradiation and Albumin-Bound Paclitaxel in people with Esophagus Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Locoregional control rate (time frame: 3 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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