NCT06186609

Brief Summary

Concurrent chemoradiotherapy is now considered to be the standard treatment modality for esophageal cancer patients who are medically unfit for surgery. However, elderly patients have limitations in their ability to tolerate concurrent chemoradiotherapy in comparison to nonelderly patients because of medical comorbidities and reduced functional reserve of organs. Immune checkpoint inhibitors, including PD-1 inhibitor, have been used in a large number of clinical studies on esophageal cancer and have achieved certain results. PD-1 inhibitor combined with radiotherapy may be a new strategy for elderly patients with esophageal cancer. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with radiotherapy in the treatment of elderly patients with esophageal cancer. PD-1 inhibitor was delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started Jul 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

January 2, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

January 2, 2023

Last Update Submit

December 15, 2023

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Elderly patientEsophageal CancerPD-1 inhibitorRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    The time from the start of treatment to disease progression as assessed by the treating physicians in the study (investigator-assessed)

    Two years

Secondary Outcomes (1)

  • Overall Survival

    Three years

Study Arms (1)

Experiment Arm

EXPERIMENTAL

PD-1 inhibitor combined with radiotherapy

Drug: PD-1 inhibitor 200mg per three to four weeks, for one year

Interventions

PD-1 inhibitor 200mg per three to four weeks, for one yearDRUG

PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year. Radiotherapy:56-60Gy/28-30 fraction.

Also known as: radiotherapy
Experiment Arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 70 years or above
  • Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy
  • Stage II-IVa according to the AJCC TNM staging system
  • Estimated survival time ≥ 3 months
  • Karnofsky performance score ≥70
  • Normal blood routine, liver and kidney function less than 2 times of the normal upper limit
  • Without mental disorders, cooperate with treatment and follow-up
  • Have fully understood this study and voluntarily signed the informed consent

You may not qualify if:

  • Esophageal bronchial fistula or esophageal mediastinal fistula
  • Patients who have participated in other clinical trials before this treatment
  • Severe heart, liver and/or kidney dysfunction
  • Serious infectious diseases
  • EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy
  • Severe autoimmune disease
  • Relapse disease or distant metastasis
  • Combined with other malignant tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Interventions

Immune Checkpoint InhibitorsRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic UsesTherapeutics

Study Officials

  • Yu Weiwei

    Department of Radiation Oncology, Affiliated Hospital of Nantong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Weiwei

CONTACT

18930174528yww333@126.com

Song Haotian

CONTACT

19827031325sht980212@163.com

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
professor

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 2, 2024

Study Start

July 1, 2023

Primary Completion

June 10, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

CN(1)