Esophageal Squamous Cell CarcinomaPhase 1/2NCT05541445
Pembrolizumab Plus CRT Followed by Surgery in Upper ESCC
A Phase 1/2 study testing Pembrolizumab in people with Esophageal Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Through a prospective, single-center, single-arm, phase Ib/II study, we aim to explore the safety and feasibility of a new treatment mode for upper esophageal cancer, which is that pembrolizumab combined with chemoradiotherapy as neoadjuvant therapy and then followed by radical surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Dec 2024
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form before enrollment;
- Be aged 18-80 years old, and be male or female;
- Have potentially upper ESCC (upper edge of tumor ≤ 5cm from esophageal entrance) diagnosed with cT1-3N1-2M0 or cT2-3N0M0 (AJCC 8th);
- Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
- No previous treatments;
- Be eligible for R0 resection before treatment;
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- Demonstrate adequate organ function; all screening laboratory tests will be performed within 10 days of treatment initiation;
- Have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication if they are a female subject with childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. "Newly obtained" is defined as a specimen obtained up to 4 weeks (28 days) before the initiation of treatment on Day 10. Subjects for whom newly obtained samples cannot be provided (e.g., as newly obtained sample is inaccessible or due to subject safety concerns) may submit an archived specimen, but only with the agreement of the sponsor;
- 11. Be expected to survive >6 months; 12. Join the clinical study on a completely voluntary basis, demonstrate good adherence, and cooperate with the follow-up assessments for safety and survival
Who cannot join
- Have undergone any previous therapy (e.g., an operation, radiotherapy, immunotherapy, or chemotherapy) for ESCC;
- Have a history of other malignant tumor;
- Be ineligible or have a contraindication for esophagectomy;
- Have a history of other anti-PD-1/PD-L1 therapies, or have a known history of an allergy to macromolecular protein preparations or any component of PD-1;
- Have a diagnosis of immunodeficiency or have received chronic systemic steroid therapy (in doses >10 mg daily of a prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of the study drug;
- Have an active autoimmune disease that required systemic treatment in the past 2 years (e.g., the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs);
- Have poorly controlled cardiac symptoms or cardiac diseases;
- Have a history or evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yong Li, MD, +8613831120879, liyongdoctor@126.com
About this study
Official title: A Prospective, Single-arm Phase Ib/II Study to Explore the Safety and Efficacy of Pembrolizumab Combined With Neoadjuvant Chemoradiotherapy (CRT) Followed by Surgery for Upper Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Through a prospective, single-center, single-arm, phase Ib/II study, we aim to explore the safety and feasibility of a new treatment mode for upper esophageal cancer, which is that pembrolizumab combined with chemoradiotherapy as neoadjuvant therapy and then followed by radical surgery.
Read the detailed description
Treatment includes induction treatment, sequential treatment and maintenance treatment.
- Preoperative neoadjuvant therapy 1) Induction therapy (2 cycles): Immunotherapy+Chemotherapy Pembrolizumab 200mg, IV, D1, q3w, Albumin paclitaxel, 125mg/m2, IV, D1/D8, q3w; Cisplatin, 70mg/m2 in total, IV, given in three times, q3w. 2) Sequential treatment: Immunotherapy+Chemoradiotherapy Pembrolizumab 200mg, IV, D1, q3w, 2 cycles; Albumin paclitaxel, 100mg, IV, D1, QW, 4 cycles; Cisplatin, 20mg/m2, IV, D1, QW, 4 cycles. Radiotherapy: PTV: 44gy/2gy/22fx, 5 days a week, 5 weeks in total.
- Surgery 4-8 weeks after the end of the neoadjuvant therapy, the operation can be performed only when the indexes of leukocyte, platelet, liver and kidney function of the patient are normal. The operation aims to achieve R0 resection with laryngeal preservation.
- Postoperative adjuvant treatment Patients who did not reach pCR after operation were given pembrolizumab 200mg, IV, D1, q3w 4-6 weeks after operation until 1 year, disease progression or intolerable toxicity.
- Follow-up period Patients will be continuously monitored during the study. The enrolled subjects will be closely followed up for 2 years.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Pembrolizumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called IO combined therapy
The subjects first receive induction therapy with pembrolizumab combined with chemotherapy for 6 weeks, and then receive sequential therapy with pembrolizumab combined with concurrent chemoradiotherapy for 6 weeks, and receive surgical treatment within 4-8 weeks after neoadjuvant therapy. For patients whose postoperative pathology is confirmed as PCR (pathological complete response), the patients will be observed with long-time follow-up; If the postoperative pathology is confirmed as non-PCR, pembrolizumab will be administrated until 1 year or disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Immunotherapy combined with chemotherapy and radiotherapy Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response
Viable tumor comprised ≤ 10% of resected tumor specimens
Measured: 4 months
Secondary outcomes (5)
R0 resection rate
R0 resection rate
Measured: At time of surgery
Larynx preservation rate
Larynx preservation rate
Measured: At time of surgery
Disease-free survival (DFS)
DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer (including toxicity), whichever occurred first.
Measured: 24 months
Local-regional recurrence free survival (LRRFS)
LRRFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of local-regional relapse after radical resection at primary site or death related to cancer (including toxicity), whichever occurred first.
Measured: 24 months
Overall survival (OS)
Time from the enrollment to death of any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie He, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541445
- Sponsor's protocol ID
- Upper EC program
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Phase Ib/II Study to Explore the Safety and Efficacy of Pembrolizumab Combined With Neoadjuvant Chemoradiotherapy (CRT) Followed by Surgery for Upper Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
- ClinicalTrials.gov ID
- NCT05541445
- Acronym / sponsor ID
- Upper EC program
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Sep 2022 (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.
Through a prospective, single-center, single-arm, phase Ib/II study, we aim to explore the safety and feasibility of a new treatment mode for upper esophageal cancer, which is that pembrolizumab combined with chemoradiotherapy as neoadjuvant therapy and then followed by radical surgery.
Detailed description
Treatment includes induction treatment, sequential treatment and maintenance treatment.
- Preoperative neoadjuvant therapy 1) Induction therapy (2 cycles): Immunotherapy+Chemotherapy Pembrolizumab 200mg, IV, D1, q3w, Albumin paclitaxel, 125mg/m2, IV, D1/D8, q3w; Cisplatin, 70mg/m2 in total, IV, given in three times, q3w. 2) Sequential treatment: Immunotherapy+Chemoradiotherapy Pembrolizumab 200mg, IV, D1, q3w, 2 cycles; Albumin paclitaxel, 100mg, IV, D1, QW, 4 cycles; Cisplatin, 20mg/m2, IV, D1, QW, 4 cycles. Radiotherapy: PTV: 44gy/2gy/22fx, 5 days a week, 5 weeks in total.
- Surgery 4-8 weeks after the end of the neoadjuvant therapy, the operation can be performed only when the indexes of leukocyte, platelet, liver and kidney function of the patient are normal. The operation aims to achieve R0 resection with laryngeal preservation.
- Postoperative adjuvant treatment Patients who did not reach pCR after operation were given pembrolizumab 200mg, IV, D1, q3w 4-6 weeks after operation until 1 year, disease progression or intolerable toxicity.
- Follow-up period Patients will be continuously monitored during the study. The enrolled subjects will be closely followed up for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: PembrolizumabImmunotherapy combined with chemotherapy and radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign the informed consent form before enrollment;
- Be aged 18-80 years old, and be male or female;
- Have potentially upper ESCC (upper edge of tumor ≤ 5cm from esophageal entrance) diagnosed with cT1-3N1-2M0 or cT2-3N0M0 (AJCC 8th);
- Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
- No previous treatments;
Key exclusion criteria (8 listed)
- Have undergone any previous therapy (e.g., an operation, radiotherapy, immunotherapy, or chemotherapy) for ESCC;
- Have a history of other malignant tumor;
- Be ineligible or have a contraindication for esophagectomy;
- Have a history of other anti-PD-1/PD-L1 therapies, or have a known history of an allergy to macromolecular protein preparations or any component of PD-1;
- Have a diagnosis of immunodeficiency or have received chronic systemic steroid therapy (in doses >10 mg daily of a prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of the study drug;
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 |
|---|---|---|
| PembrolizumabAlso: IO combined therapyThe subjects first receive induction therapy with pembrolizumab combined with chemotherapy for 6 weeks, and then receive sequential therapy with pembrolizumab combined with concurrent chemoradiotherapy for 6 weeks, and receive surgical treatment within 4-8 weeks after neoadjuvant therapy. For patients whose postoperative pathology is confirmed as PCR (pathological complete response), the patients will be observed with long-time follow-up; If the postoperative pathology is confirmed as non-PCR, pembrolizumab will be administrated until 1 year or disease progression or intolerable toxicity. | Drug | Experimental arm |
Primary outcome
Major pathologic response
Time frame: 4 months
Viable tumor comprised ≤ 10% of resected tumor specimens
5 secondary outcomes
R0 resection rate
Time frame: At time of surgery
Larynx preservation rate
Time frame: At time of surgery
Disease-free survival (DFS)
Time frame: 24 months
Local-regional recurrence free survival (LRRFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Jie He, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab in people with Esophageal Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 10 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 15 Sep 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yong Li, MD (+8613831120879, liyongdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (time frame: 4 months). 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 15 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.