Trial · NCT02730546
Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
NCT02730546, Phase 1, Phase 2, Completed, Mayo Clinic; results first posted 2022-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery. Trials, record NCT02730546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02730546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery
- NCT number
- NCT02730546
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
Gastric Cardia Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Stage IB Gastric Cancer AJCC v7, Stage II Gastric Cancer AJCC v7, Stage IIA Gastric Cancer AJCC v7, Stage IIB Gastric Cancer AJCC v7, Stage IIIA Gastric Cancer AJCC v7, Stage IIIB Gastric Cancer AJCC v7
- Interventions
Carboplatin, Computed Tomography, Fluorouracil, Laboratory Biomarker Analysis, Leucovorin Calcium, Oxaliplatin, Paclitaxel, Pembrolizumab, Positron Emission Tomography, Radiation Therapy, Therapeutic Conventional Surgery
- First posted
- 2016-04-06
- Last updated
- 2025-06-22
- Results first posted
- 2022-08-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Response (PathCR) Rate | Up to 3 years | Defined as number of patients with pathologic complete responses (pCR) divided by total evaluable patients. pCR is defined as no recognized cancer and margins free of tumor as found by the pathologist following resection of the esophageal specimen and accompanying lymph nodes. |
| Secondary | Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate | Up to 3 years | Defined as the number of patients who achieve R0 resection divided by total number of evaluable patients. |
| Secondary | Disease-free Survival (DFS) | Up to 3 years | Defined as the time from the date of study registration to the date of death due to any cause |
| Secondary | Time to Relapse (TTR) | Up to 3 years | Defined as the time from the date of study registration to the date of 1st documented relapse/recurrence among patients who achieve R0 resection |
| Secondary | Overall Survival (OS) at Two Years | 2 years | The distribution of OS will be estimated using the method of Kaplan-Meier. Two-year OS rate and confidence interval will be estimated based on Kaplan-Meier curve. |
| Secondary | Progression-free Survival (PFS) Rate at Two Years | 2 years | The distribution of PFS will be estimated using the method of Kaplan-Meier. Two-year PFS rate and confidence interval will be estimated based on Kaplan-Meier curve. |
| Secondary | Number of Patients Experiencing Dose-limiting Toxicities (DLTs) | Up to 3 years | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse events that are possibly, probably or definitely related to study treatments will be recorded for each patient. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathological Complete Response (PathCR) Rate | Up to 3 years | percentage of patients | NUMBER | |
| SECONDARY | Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease-free Survival (DFS) | Up to 3 years | All patients that achieved an R0 | months | MEDIAN |
| SECONDARY | Time to Relapse (TTR) | Up to 3 years | All patients that achieved an R0 | months | MEDIAN |
| SECONDARY | Overall Survival (OS) at Two Years | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) Rate at Two Years | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Experiencing Dose-limiting Toxicities (DLTs) | Up to 3 years | The 16 eligible patients enrolled in the phase 1b portion of the study were assessed for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathological Complete Response (PathCR) Rate | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 22.6 | 95% Confidence Interval 11.4 to 39.8 | percentage of patients | |
| Complete Resection With no Tumor Within 1 mm of the Resection Margins (R0) Rate | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 28 | Participants | ||
| Disease-free Survival (DFS) | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 8.87 | 95% Confidence Interval 7.46 to NA | months | |
| Time to Relapse (TTR) | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 8.87 | 95% Confidence Interval 7.46 to NA | months | |
| Overall Survival (OS) at Two Years | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 63.3 | 95% Confidence Interval 47.4 to 84.4 | percentage of participants | |
| Progression-free Survival (PFS) Rate at Two Years | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 16.7 | 95% Confidence Interval 6.0 to 46.5 | percentage of participants | |
| Number of Patients Experiencing Dose-limiting Toxicities (DLTs) | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 31 | |
| Overall Study | COMPLETED | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 31 | |
| Overall Study | NOT COMPLETED | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 0 |
Source ClinicalTrials.gov
Adverse events101
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 8 | 31 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Myocarditis | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Palpitations | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Pericardial effusion | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 2 | 31 | 2 |
| other | Hyperthyroidism | Endocrine disorders | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 1 | 31 | 1 |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 11 | 31 |
| Total, other adverse events | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 31 | 31 |
| Total, serious adverse events | Treatment (Pembrolizumab, Chemotherapy, Radiation, Surgery) | 13 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02730546
GET https://conductscience.org/api/trials/v1/NCT02730546/events?page=2