Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2/3ONTRESCCNCT06907602
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2/3 study testing Chemotherapy, Immunotherapy (Pembrolizumab) and radiotherapy in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Chemotherapy, Immunotherapy (Pembrolizumab) and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2024to 31 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- male or female
- Age ≥ 18 years old
- Pathological confirmation of esophageal squamous cell carcinoma
- Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
- No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
- Tumor longitudinal diameter ≤ 10cm
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- The tumor did not involve the dentate line
- ECOG score 0 or 1
- No hematological diseases, no liver or kidney dysfunction
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 11g/L
- ALT ≤ 2 times the upper limit of normal value
- TBil ≤ 1.5 times the upper limit of normal value
- Creatinine clearance rate (Cockroft) ≥ 50ml/min
- Obtain informed consent
Who cannot join
- T staging evaluation is T1/T2
- PET/CT and other evaluations show distant metastasis (M1)
- Planned pregnancy or patients during pregnancy or lactation
- History of previous chemotherapy, radiation therapy, or immunotherapy
- Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
- Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
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- Previous autoimmune disease requiring systemic treatment within 2 years
- Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
- Previous motor or sensory neurotoxic diseases
- Previous mental illness
- Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
- Acute infectious diseases requiring systemic treatment
- Previous HIV, HBV, or HCV infections
- Previously received stem cell or solid organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Li Li, +86-10-69152630, Lili4037@pumch.cn
About this study
Official title: Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.
However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
- Being tested
- Chemotherapy, Immunotherapy (Pembrolizumab), radiotherapy
- Keywords
- esophageal squamous cell carcinoma, neoadjuvant chemoimmunotherapy, radiotherapy
- 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.
ChemotherapyDrug
carboplatin plus nab-paclitaxel
Immunotherapy (Pembrolizumab)Drug
Pembrolizumab
radiotherapyRadiation
40-45Gy/20fx，5 times a week
| Study group | Role | What they receive |
|---|---|---|
| 2 cycles chemoimmunotherapy plus surgery | Experimental | 2 cycles chemoimmunotherapy and surgery Receives: Drug: Chemotherapy; Drug: Immunotherapy (Pembrolizumab) |
| 4 cycles chemoimmunotherapy plus surgery | Experimental | 4 cycles chemoimmunotherapy and surgery Receives: Drug: Chemotherapy; Drug: Immunotherapy (Pembrolizumab) |
| 4 cycles chemoimmunotherapy plus radiotherapy and surgery | Experimental | 4 cycles chemoimmunotherapy plus radiotherapy and surgery Receives: Drug: Chemotherapy; Drug: Immunotherapy (Pembrolizumab); Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response
Postoperative pathology according to CAP classification.
Measured: After surgery
2-year and 5-year overall survival
overall survival after 2 years and 5 years
Measured: 2 years and 5 years after therapy
Secondary outcomes (4)
Adverse effect incidence
Adverse effect according to CTCAE and RTOG criteria
Measured: 1 years after therapy
R0 resection rate
Measured: After surgery
postoperative complications
postoperative complications according to Clavien-Dindo classification
Measured: After surgery
2-year and 5-year disease-free survival
disease-free survival after 2 years and 5 years
Measured: 2 years and 5 years after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start12 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907602
- Sponsor's protocol ID
- Keypoint 002
- Acronym
- ONTRESCC
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06907602
- Acronym / sponsor ID
- ONTRESCC / Keypoint 002
- Keywords
- esophageal squamous cell carcinoma, neoadjuvant chemoimmunotherapy, radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Apr 2025 (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.
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.
However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 cycles chemoimmunotherapy plus surgery | Experimental | Drug: Chemotherapy, Drug: Immunotherapy (Pembrolizumab)2 cycles chemoimmunotherapy and surgery |
| 4 cycles chemoimmunotherapy plus surgery | Experimental | Drug: Chemotherapy, Drug: Immunotherapy (Pembrolizumab)4 cycles chemoimmunotherapy and surgery |
| 4 cycles chemoimmunotherapy plus radiotherapy and surgery | Experimental | Drug: Chemotherapy, Drug: Immunotherapy (Pembrolizumab), Radiation: radiotherapy4 cycles chemoimmunotherapy plus radiotherapy and surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- male or female
- Age ≥ 18 years old
- Pathological confirmation of esophageal squamous cell carcinoma
- Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
- No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
Key exclusion criteria (14 listed)
- T staging evaluation is T1/T2
- PET/CT and other evaluations show distant metastasis (M1)
- Planned pregnancy or patients during pregnancy or lactation
- History of previous chemotherapy, radiation therapy, or immunotherapy
- Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
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 |
|---|---|---|
| Chemotherapycarboplatin plus nab-paclitaxel | Drug | 2 cycles chemoimmunotherapy plus surgery, 4 cycles chemoimmunotherapy plus radiotherapy and surgery, 4 cycles chemoimmunotherapy plus surgery |
| Immunotherapy (Pembrolizumab)Pembrolizumab | Drug | 2 cycles chemoimmunotherapy plus surgery, 4 cycles chemoimmunotherapy plus radiotherapy and surgery, 4 cycles chemoimmunotherapy plus surgery |
| radiotherapy40-45Gy/20fx，5 times a week | Radiation | 4 cycles chemoimmunotherapy plus radiotherapy and surgery |
Primary outcome
Pathological response
Time frame: After surgery
Postoperative pathology according to CAP classification.
2-year and 5-year overall survival
Time frame: 2 years and 5 years after therapy
overall survival after 2 years and 5 years
4 secondary outcomes
Adverse effect incidence
Time frame: 1 years after therapy
R0 resection rate
Time frame: After surgery
postoperative complications
Time frame: After surgery
2-year and 5-year disease-free survival
Time frame: 2 years and 5 years after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chemotherapy, Immunotherapy (Pembrolizumab) and radiotherapy in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital 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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Li (+86-10-69152630, Lili4037@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response (time frame: After surgery). The study lists 2 primary outcomes in all. 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 Apr 2025.