Esophageal CancerPhase 2NCT06304350
Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Combination of pembrolizumab and platinum containing dual drugs in people with Esophageal Cancer, run by Tongji University at 1 site in China.
Trial summary
This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Combination of pembrolizumab and platinum containing dual drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2024to 31 Dec 2026
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
- Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
- Age range from 18 to 75 years old;
- There are no surgical contraindications in the preoperative evaluation of various organ functions;
- The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value;
- Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years;
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- Expected to achieve R0 resection;
- Physical state ECOG 0-1;
- The subjects must understand and sign the informed consent form
Who cannot join
- Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
- Not suitable for surgery or with surgical contraindications;
- Have a history of other anti PD-L1/PD-1 treatments;
- Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
- Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
- Patients with poor control of heart disease
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- Pregnant or lactating female patients;
- For patients with drug allergies in the protocol.
- Exit criteria：
- Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment:
- The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
- The surgical procedure violates the plan;
- Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics;
- According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
- Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported together;
- Missing subjects. All subjects who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival analysis and toxicity evaluation for the corresponding group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fu Yang, DM contact
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Jiang Fan, MD, 02163240090, fan_jiang@tongji.edu.cn
Jiang Fan, MD
About this study
Official title: A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study
Read the detailed description
This study is a prospective, single center, open label, single arm Phase II clinical study. Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study, who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was performed. The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed, with pCR and MPR as the main research endpoints.
- Conditions
- Esophageal Cancer
- Being tested
- Combination of pembrolizumab and platinum containing dual drugs
- Keywords
- esophageal cancer；, Pembrolizumab；, Neoadjuvant therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of pembrolizumab and platinum containing dual drugsDrug
After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery
| Study group | Role | What they receive |
|---|---|---|
| Combination of pembrolizumab and platinum containing dual drugs | Experimental | After 2 courses of treatment with pembrolizumab combined with platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed, and postoperative pembrolizumab immunomaintenance therapy continued Receives: Drug: Combination of pembrolizumab and platinum containing dual drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission (pCR)
Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes
Measured: in two weeks after the surgical resection
Secondary outcomes (5)
Major pathological remission (MPR)
The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%.
Measured: in two weeks after the surgical resection
R0 resection rate
Measured: in two weeks after the surgical resection
Progression free survival (PFS)
Measured: receiving therapy，up to approximately 2years.
Total survival time (OS)
Measured: The time from the patient's randomization receiving therapy to death from any cause，up to approximately 2years
Safety (incidence of adverse drug reactions)
Measured: Randomly group patients to receive treatment for up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start17 Feb 2024
- Primary completion25 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304350
- Sponsor's protocol ID
- SGHDOT-24-20
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06304350
- Acronym / sponsor ID
- SGHDOT-24-20
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer；, Pembrolizumab；, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 25 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 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.
This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study
Detailed description
This study is a prospective, single center, open label, single arm Phase II clinical study. Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study, who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was performed. The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed, with pCR and MPR as the main research endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of pembrolizumab and platinum containing dual drugs | Experimental | Drug: Combination of pembrolizumab and platinum containing dual drugsAfter 2 courses of treatment with pembrolizumab combined with platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed, and postoperative pembrolizumab immunomaintenance therapy continued |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
- Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
- Age range from 18 to 75 years old;
- There are no surgical contraindications in the preoperative evaluation of various organ functions;
- The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value;
Key exclusion criteria (16 listed)
- Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
- Not suitable for surgery or with surgical contraindications;
- Have a history of other anti PD-L1/PD-1 treatments;
- Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
- Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
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 |
|---|---|---|
| Combination of pembrolizumab and platinum containing dual drugsAfter 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery | Drug | Combination of pembrolizumab and platinum containing dual drugs |
Primary outcome
Pathological complete remission (pCR)
Time frame: in two weeks after the surgical resection
Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes
5 secondary outcomes
Major pathological remission (MPR)
Time frame: in two weeks after the surgical resection
R0 resection rate
Time frame: in two weeks after the surgical resection
Progression free survival (PFS)
Time frame: receiving therapy，up to approximately 2years.
Total survival time (OS)
Time frame: The time from the patient's randomization receiving therapy to death from any cause，up to approximately 2years
Safety (incidence of adverse drug reactions)
Time frame: Randomly group patients to receive treatment for up to two years
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 13 Mar 2024.
- 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.
Fu Yang, DM contact
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 Combination of pembrolizumab and platinum containing dual drugs in people with Esophageal Cancer, run by Tongji 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 9 inclusion and 16 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 13 Mar 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?
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 Jiang Fan, MD (15901013210, fan_jiang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (pCR) (time frame: in two weeks after the surgical resection). 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 13 Mar 2024.