NeoadjuventPhase 2NCT06006650
Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
A Phase 2 study testing Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin in people with Neoadjuvent and PD-1 Inhibitor, run by Tang-Du Hospital at 3 sites in China.
Trial summary
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvent, PD-1 Inhibitor, Chemotherapy
- What is being tested?
- Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2022to 31 Dec 2031
- 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
- 1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy; 5.ECOG PS score 0-1. 6.Organs function well:Hemoglobin ≥100g/L, white blood cell count ≥410^9/L or neutrophil count ≥2.510^9/L, platelet count ≥10010^9/L, serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal,Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein <+, if urinary protein +, 24-hour total protein must be <500mg, blood glucose:In patients with normal-range and/or diabetes under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least 2L;If the baseline FEV1 was <2L, the predicted FEV1 after surgery was >800ml, and the cardiac function was: no myocardial infarction within 1 year;Unstable angina pectoris;Asymptomatic severe arrhythmias;The centerless function is incomplete; 7.Non-surgically sterilized women, or women of reproductive age, need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during and for 3 months after the end of the study treatment period.Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 hours before study enrollment.And must be non-lactation period;For male patients with partners of women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last dose of treatment; 8.Sign an informed consent form.
Who cannot join
- Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.
- History of subtotal gastrectomy;
- accompanied by a second primary cancer;
- Tumor metabolic imaging prior to treatment suggested distant metastasis.
- people who have previously received chemoradiotherapy;
- preesophageal perforation signs
Show all 21Show fewer
- pregnant women of reproductive age;
- Any active autoimmune disease or a history of autoimmune disease (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.);
- People with the following active infectious diseases, including active tuberculosis, hepatitis, and known human immunodeficiency virus (HIV) infection;
- Someone who has a known or concomitant hemorrhagic disease or other uncontrollable disease that cannot be treated surgically;
- Physical examination or clinical trial findings that researchers believe could interfere with the outcome or put the patient at increased risk of treatment complications;
- A previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically documented active interstitial lung disease, and the presence of idiopathic pulmonary fibrosis on CT scan at baseline;Uncontrolled massive pleural or pericardial effusion;
- unstable systemic diseases (active infection, moderately severe chronic obstructive pulmonary disease (copd), poorly controlled hypertension, unstable angina and congestive heart failure, 6 months occurrence of myocardial infarction, drug control severe mental disorders, liver, kidney or other metabolic disease, nerve mental disease such as Alzheimer 's disease);
- Gastrointestinal dysfunction, malabsorption syndrome, active gastrointestinal ulcers;
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies;
- Receiving any investigational drug within 4 weeks before the first use of the investigational drug;
- Enroll in another clinical study at the same time, unless it's an observational (non-intervention) clinical study or an intervention clinical study follow-up;
- Subjects who require systematic treatment with corticosteroids (equivalent dose of prednisone > 10 mg per day) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug, except for the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea, and vomiting.Other special circumstances, need to communicate with the sponsor.In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses > 10mg/ day in response to prednisone are permitted;
- People who have been vaccinated with anti-tumor vaccine or who have been vaccinated with live vaccine within 4 weeks prior to the first administration of the study drug;
- Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- Congenital or acquired immunodeficiency disease or a history of organ transplantation;A history of allergies to monoclonal antibodies, albumin paclitaxel, 5-fluorouracil, cisplatin, and other platinum-based drugs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
HongTao Duan, MD contact
China3 sites, 3 recruiting
- Recruiting
Tangdu Hospital of the Fourth Millitary Medical University
Xi'an, Shaanxi, 710038
Xiaolong Yan, MD, +862984717558, yanxiaolong@fmmu.edu.cn
Xiaolong Yan, MD
- Recruiting
Tangdu Hospital, the Air Force Military University
Xi'an, 710038
Xiaolong Yan, Dr., 029-847171569, yanxiaolong@fmmu.edu.cn
- Recruiting
Hongtao Duan
Xi’an, Shanxi, 710038
Hongtao Duan, MD, 646014852@qq.com
Xiaolong Yan, MD
About this study
Official title: Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Read the detailed description
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Study Endpoints Primary Endpoints PCR: This was assessed by examining the postoperative pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes.
Safety: Adverse reactions during neoadjuvant therapy were recorded following CTCAE version 5.0 guidelines. Perioperative complications were assessed using the Clavien-Dindo classification. Grade I complications included any deviation from the normal postoperative recovery process without requiring medical, surgical, endoscopic, or radiological intervention. Acceptable medical management included antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physical therapy. Bedside open incisional infections were included under this category. Grade II complications were those that required medications beyond those used for treating Grade 1 complications, including blood transfusions and total parenteral nutrition. Grade III complications were those that required surgical, endoscopic, or radiological intervention. Grade IV complications were those considered life-threatening and requiring mid-term care or admission to an intensive care unit (including central nervous system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid hemorrhage, and excluding transient ischemic attacks). Grade V complications included patient deaths.
Secondary Endpoints
- Major pathological response (MPR) refers to the proportion of residual tumor cells in the primary tumor and lymph nodes in the postoperative pathological tissue being <10%, or the primary tumor completely disappearing, and the number of positive lymph nodes being ≤1. 2) R0 resection rate: R0 resection was defined as achieving negative upper and lower resection margins. 3) RECIST Criteria Assessment: Complete response (CR): complete response of target lesions; PR: >30% regression of target lesions; Non-CR/Non-PD: target lesions did not completely disappear and did not increase by >20%, or other new lesions appeared in the body; Stable disease (SD): target lesions were reduced or increased by <20%; Progressive disease (PD): target lesions had increased by >20%.
Statistical Methods The sample size was determined using Simon's two-stage design. With a minimum expected pCR of 20% and an expected pCR of 40%, a Type I error (α) of 0.05, and a Type II error of 80%, a sample size of 34 was calculated. In the first stage, 17 patients were enrolled. The study was carefully monitored to limit the number of pCR cases to three or below, and any increase in the risk of surgery and mortality due to the treatment regimen would have led to its discontinuation. All continuous variables were presented as frequencies. Statistical significance was set at P <0.05.
- Being tested
- Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
- 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.
Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, CisplatinDrug
Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab Plus Albumin Paclitaxel and Cisplatin | Experimental | Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ albumin paclitaxel 100mg/m2, d1/d8/d15 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy Receives: Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin |
| Pembrolizumab Plus 5-fluorouracil and Cisplatin | Active comparator | Preoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ 5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy Receives: Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin |
| 5-fluorouracil and Cisplatin | Active comparator | Preoperative neoadjuvant (5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy Receives: Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate (pCR)
Pathologic complete response rate (pCR)
Measured: up to 4 months
Secondary outcomes (3)
Major pathological response(MPR)
Major pathological response(MPR)
Measured: up to 4 months
Event free survival(EFS)
Event free survival(EFS)
Measured: up to 10 years
Overall survival(OS)
Overall survival(OS)
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoadjuventStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yanxiaolong, Tang-Du Hospital
- Investigators
- Xiaolong Yan, MD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006650
- Sponsor's protocol ID
- K202208-28
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT06006650
- Acronym / sponsor ID
- K202208-28
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 23 Aug 2023 (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.
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Detailed description
The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
Study Endpoints Primary Endpoints PCR: This was assessed by examining the postoperative pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes.
Safety: Adverse reactions during neoadjuvant therapy were recorded following CTCAE version 5.0 guidelines. Perioperative complications were assessed using the Clavien-Dindo classification. Grade I complications included any deviation from the normal postoperative recovery process without requiring medical, surgical, endoscopic, or radiological intervention. Acceptable medical management included antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physical therapy. Bedside open incisional infections were included under this category. Grade II complications were those that required medications beyond those used for treating Grade 1 complications, including blood transfusions and total parenteral nutrition. Grade III complications were those that required surgical, endoscopic, or radiological intervention. Grade IV complications were those considered life-threatening and requiring mid-term care or admission to an intensive care unit (including central nervous system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid hemorrhage, and excluding transient ischemic attacks). Grade V complications included patient deaths.
Secondary Endpoints
- Major pathological response (MPR) refers to the proportion of residual tumor cells in the primary tumor and lymph nodes in the postoperative pathological tissue being <10%, or the primary tumor completely disappearing, and the number of positive lymph nodes being ≤1. 2) R0 resection rate: R0 resection was defined as achieving negative upper and lower resection margins. 3) RECIST Criteria Assessment: Complete response (CR): complete response of target lesions; PR: >30% regression of target lesions; Non-CR/Non-PD: target lesions did not completely disappear and did not increase by >20%, or other new lesions appeared in the body; Stable disease (SD): target lesions were reduced or increased by <20%; Progressive disease (PD): target lesions had increased by >20%.
Statistical Methods The sample size was determined using Simon's two-stage design. With a minimum expected pCR of 20% and an expected pCR of 40%, a Type I error (α) of 0.05, and a Type II error of 80%, a sample size of 34 was calculated. In the first stage, 17 patients were enrolled. The study was carefully monitored to limit the number of pCR cases to three or below, and any increase in the risk of surgery and mortality due to the treatment regimen would have led to its discontinuation. All continuous variables were presented as frequencies. Statistical significance was set at P <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab Plus Albumin Paclitaxel and Cisplatin | Experimental | Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, CisplatinPreoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ albumin paclitaxel 100mg/m2, d1/d8/d15 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy |
| Pembrolizumab Plus 5-fluorouracil and Cisplatin | Active comparator | Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, CisplatinPreoperative neoadjuvant (pembrolizumab 200mg, d1 intravenously, q3w+ 5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy |
| 5-fluorouracil and Cisplatin | Active comparator | Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, CisplatinPreoperative neoadjuvant (5-fluorouracil 800mg/m2, d1-5 intravenously, q3w+ cisplatin 75mg/m2, d1 intravenously, q3w) 3 cycles + surgery + 16 cycles of postoperative pembrolizumab adjuvant therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy; 5.ECOG PS score 0-1. 6.Organs function well:Hemoglobin ≥100g/L, white blood cell count ≥410^9/L or neutrophil count ≥2.510^9/L, platelet count ≥10010^9/L, serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal,Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein <+, if urinary protein +, 24-hour total protein must be <500mg, blood glucose:In patients with normal-range and/or diabetes under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least 2L;If the baseline FEV1 was <2L, the predicted FEV1 after surgery was >800ml, and the cardiac function was: no myocardial infarction within 1 year;Unstable angina pectoris;Asymptomatic severe arrhythmias;The centerless function is incomplete; 7.Non-surgically sterilized women, or women of reproductive age, need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during and for 3 months after the end of the study treatment period.Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 hours before study enrollment.And must be non-lactation period;For male patients with partners of women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last dose of treatment; 8.Sign an informed consent form.
Key exclusion criteria (21 listed)
- Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.
- History of subtotal gastrectomy;
- accompanied by a second primary cancer;
- Tumor metabolic imaging prior to treatment suggested distant metastasis.
- people who have previously received chemoradiotherapy;
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 |
|---|---|---|
| Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, CisplatinPembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin | Drug | 5-fluorouracil and Cisplatin, Pembrolizumab Plus 5-fluorouracil and Cisplatin, Pembrolizumab Plus Albumin Paclitaxel and Cisplatin |
Primary outcome
Pathologic complete response rate (pCR)
Time frame: up to 4 months
Pathologic complete response rate (pCR)
3 secondary outcomes
Major pathological response(MPR)
Time frame: up to 4 months
Event free survival(EFS)
Time frame: up to 10 years
Overall survival(OS)
Time frame: up to 10 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 23 Aug 2023.
- 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.
HongTao Duan, MD contact
Xiaolong Yan, MD principal investigator
Tang-Du Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin in people with Neoadjuvent and PD-1 Inhibitor, run by Tang-Du Hospital at 3 sites 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 1 inclusion and 21 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Xiaolong Yan, MD (029-847171569, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (pCR) (time frame: up to 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 23 Aug 2023.