A Phase 1 interventional study of Pembrolizumab in Esophageal Squamous Cell Carcinoma, sponsored by Hecheng Li M.D., Ph.D. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Hecheng Li M.D., Ph.D · Phase 1, Interventional, and Treatment
This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.
Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical resection is thought to be the mainstay of esophageal cancer treatment and preoperative CRT is well applied in treating locally advanced esophageal cancer. In a multicohort, phase IB study, pembrolizumab was used in 23 unresectable esophageal cancer patients. In this clinical trial, the incidence of grade 3 treatment-related adverse events was 39 % without the appearance of grade 4 and higher-grade adverse event, while the overall response rate reached 30 %. The safety of immune checkpoint therapy for unresected esophageal cancers using nivolumab, a different PD-1 monoclonal antibody, has also been confirmed by high quality clinical trials.
This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy using pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Hecheng Li M.D., Ph.D is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
Exclusion Criteria:
Arm 1:preoperative pembrolizumab with chemoradiotherapy group Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 6 weeks after completion of preoperative therapy described above.
Drug: Pembrolizumab
Arm1：Pre-operative Pembrolizumab+chemoradiotherapy
Also known as: Keytruda
Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events)
The number of participants with grade 3 and higher-grade treatment-related adverse events. Adverse events were evaluated using CTCAE 4.0, grade 3 treatment-related adverse events and higher-grade adverse events were reported.
Time frame: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose
Feasibility (Number of Participants Who Finished Pembrolizumab With Chemoradiotherapy and Receive Surgery Within 4-6 Weeks After Preoperative Therapies)
The number of participants who finished pembrolizumab with chemoradiotherapy and receive surgery within 4-6 weeks after preoperative therapies.
Time frame: From date of treatment allocation until surgery or definitive chemoradiotherapy was applied, whichever came first, assessed up to 5 months
Pathologic Complete Response
Pathologic complete response was defined as the lack of all signs of cancer in tissue samples removed during surgery after treatment with pembrolizumab and chemoradiotherapy.
Time frame: Two weeks after surgery
Radiographic Response
To assess radiographic response to neoadjuvant pembrolizumab with concurrent chemoradiotherapy using RECIST 1.1. Complete metabolic response (cMR), defined as a physiological distribution of FDG uptake on PET-CT with a SUVmax value of less than 4 with no nodal uptake.
Time frame: From date of treatment allocation and during treatment period up to 3 months
| Milestone | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
The number of participants with grade 3 and higher-grade treatment-related adverse events. Adverse events were evaluated using CTCAE 4.0, grade 3 treatment-related adverse events and higher-grade adverse events were reported.
| Participants | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Safety (Number of Participants With Grade 3 and Higher-grade Treatment-related Adverse Events) | 13 |
The number of participants who finished pembrolizumab with chemoradiotherapy and receive surgery within 4-6 weeks after preoperative therapies.
| Participants | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Feasibility (Number of Participants Who Finished Pembrolizumab With Chemoradiotherapy and Receive Surgery Within 4-6 Weeks After Preoperative Therapies) | 11 |
Pathologic complete response was defined as the lack of all signs of cancer in tissue samples removed during surgery after treatment with pembrolizumab and chemoradiotherapy.
| Participants | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Pathologic Complete Response | 10 |
To assess radiographic response to neoadjuvant pembrolizumab with concurrent chemoradiotherapy using RECIST 1.1. Complete metabolic response (cMR), defined as a physiological distribution of FDG uptake on PET-CT with a SUVmax value of less than 4 with no nodal uptake.
| Participants | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Radiographic Response | 6 |
Collected over From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preoperative Pembrolizumab With Chemoradiotherapy Group | 1/20 (5%) | 13/20 (65%) | 20/20 (100%) |
| Event | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| LymphopeniaBlood and lymphatic system disorders | 12/20 |
| LeukopeniaBlood and lymphatic system disorders | 2/20 |
| Decreased neutrophil countBlood and lymphatic system disorders | 1/20 |
| Esophageal hemorrhageGastrointestinal disorders | 1/20 |
| Event | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 18/20 |
| AnemiaBlood and lymphatic system disorders | 16/20 |
| AlopeciaGeneral disorders | 11/20 |
| FatigueGeneral disorders | 11/20 |
| EsophagitisGastrointestinal disorders | 11/20 |
| AnorexiaGeneral disorders | 9/20 |
| Decreased neutrophil countBlood and lymphatic system disorders | 8/20 |
| LymphopeniaBlood and lymphatic system disorders | 8/20 |
| NauseaGastrointestinal disorders | 8/20 |
| Postoperative PneumoniaRespiratory, thoracic and mediastinal disorders | 4/18 |
| Age, Categorical(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 4 |
| Age, Continuous(years) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Median | 62 (42 to 66) |
| Sex: Female, Male(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Female | 1 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| China | 20 |
| Body Mass Index (BMI)(kg/m^2) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Median | 23.20 (15.31 to 29.06) |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| 0 | 3 |
| 1 | 17 |
| Smoking History(Participants) | Preoperative Pembrolizumab With Chemoradiotherapy Group |
|---|---|
| Non-smoker | 6 |
| Previous or current smoker | 14 |
5 further baseline measures are reported on the registry.
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Hecheng Li M.D., Ph.D