Esophageal Squamous Cell CarcinomaPhase 2NCT06186609
PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC
A Phase 2 study testing PD-1 inhibitor 200mg per three to four weeks, for one year in people with Esophageal Squamous Cell Carcinoma, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- PD-1 inhibitor 200mg per three to four weeks, for one year
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Yu Weiwei, 18930174528, yww333@126.com
Song Haotian, 19827031325, sht980212@163.com
About this study
Official title: Efficacy and Safety of PD-1 Inhibitor Combined With Radiotherapy in Treatment of Elderly Esophageal Squamous Cell Cancer
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.
Read the detailed description
Study Design Primary Purpose: To investigate the safety and efficacy of PD-1 inhibitor combined with radiotherapy for elderly patients with esophageal squamous cell carcinoma.
Study Phase: Phase II Intervention Model: PD-1 inhibitor combined with radiotherapy Number of Arms: One Masking: No Allocation: 68 patients for one single group Enrollment: 68 patients Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Esophageal squamous cell carcinoma with stage II to IVA, 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS ≥ 70, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Severe autoimmune disease, 4. Joining other clinical trial prior this study.
Intervention: 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- PD-1 inhibitor 200mg per three to four weeks, for one year
- Keywords
- Elderly patient, Esophageal Cancer, PD-1 inhibitor, Radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor 200mg per three to four weeks, for one yearDrug
Also called radiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Experiment Arm | Experimental | PD-1 inhibitor combined with radiotherapy Receives: Drug: PD-1 inhibitor 200mg per three to four weeks, for one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from the start of treatment to disease progression as assessed by the treating physicians in the study (investigator-assessed)
Measured: Two years
Secondary outcomes (1)
Overall Survival
The time from the start of treatment to death from any cause
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Jul 2023
- Primary completion10 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiwei Yu, Affiliated Hospital of Nantong University
- Investigators
- Yu Weiwei, Principal investigator, Department of Radiation Oncology, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186609
- Sponsor's protocol ID
- 02121998
- Status last verified
- Dec 2023
- First submitted
- 2 Jan 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-1 Inhibitor Combined With Radiotherapy in Treatment of Elderly Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT06186609
- Acronym / sponsor ID
- 02121998
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Elderly patient, Esophageal Cancer, PD-1 inhibitor, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design Primary Purpose: To investigate the safety and efficacy of PD-1 inhibitor combined with radiotherapy for elderly patients with esophageal squamous cell carcinoma.
Study Phase: Phase II Intervention Model: PD-1 inhibitor combined with radiotherapy Number of Arms: One Masking: No Allocation: 68 patients for one single group Enrollment: 68 patients Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Esophageal squamous cell carcinoma with stage II to IVA, 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS ≥ 70, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Severe autoimmune disease, 4. Joining other clinical trial prior this study.
Intervention: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment Arm | Experimental | Drug: PD-1 inhibitor 200mg per three to four weeks, for one yearPD-1 inhibitor combined with radiotherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 inhibitor 200mg per three to four weeks, for one yearAlso: radiotherapyPD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year. Radiotherapy:56-60Gy/28-30 fraction. | Drug | Experiment Arm |
Primary outcome
Progression-free survival
Time frame: Two years
The time from the start of treatment to disease progression as assessed by the treating physicians in the study (investigator-assessed)
1 secondary outcome
Overall Survival
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Weiwei principal investigator
Department of Radiation Oncology, Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 inhibitor 200mg per three to four weeks, for one year in people with Esophageal Squamous Cell Carcinoma, run by Affiliated Hospital of Nantong University at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Weiwei (18930174528, yww333@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.