A Phase 1/2 interventional study of Radiotherapy and Nivolumab in Gastric Cancer, sponsored by Fukushima Medical University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Fukushima Medical University · Phase 1/2, Interventional, and Treatment
This study aims to evaluate safety and efficacy of nivolumab (anti-PD-1 antibody), which is approved as tertiary therapy, and neoadjuvant short-term limited local radiotherapy in patients with unresectable recurrent gastric cancer who progressed (intolerance or PD) after standard treatment (primary and secondary chemotherapy) and have more than one lesion assessable in diagnostic imaging (one lesion must be >=2cm).
In patients with unresectable recurrent gastric cancer who progressed (intolerance or PD) after standard treatment (primary and secondary chemotherapy) and have more than one lesion assessable in diagnostic imaging (one lesion must be >=2cm), localized short-term radiotherapy of 22.5 Gy/5 fractions/5 days is applied to a symptomatic lesion or the largest asymptomatic lesion suitable for irradiation (Day 1-5). Nivolumab is administered starting from Day 15-22 at a dose of 3 mg/kg (body wait) or 240 mg/body every 2 weeks to a total of 6 courses (end of intervention).
The patients are observed up to Day 180±14 and evaluated on Day 180±14 (end of study).
Exclusion Criteria:
Localized short-term radiotherapy (22.5 Gy/5 fractions/5 days, Day 1-5) + nivolumab (starting on Day 15-22, a dose of 3 mg/kg (body weight) or 240 mg/body, every 2 weeks to a total of 6 courses)
Radiation: Radiotherapy · Drug: Nivolumab
Radiotherapy of 22.5 Gy/5 fractions/5 days was given to a symptomatic lesion or the largest asymptomatic lesion suitable for irradiation from Day 1.
Nivolumab was administered intravenously starting on Day 15-22 at a dose of 3 mg/kg (body weight) or 240 mg/body every 2 weeks to a total of 6 courses of administration.
Also known as: Opdivo
Disease Control Rate
Analysis item: Disease control rate of non-irradiated target lesions. The rate of patients with a best overall response of stable disease (SD) or better confirmed by 180 days, starting from the start date of radiotherapy. The RECIST Guidelines Version 1.1 was used to determine overall response such as complete response (CR), partial response (PR), SD, and progressive disease (PD) at each imaging time. If imaging is not available, the patient is considered deficient (NE).
Time frame: 6 months
Median Survival Time
Overall survival is defined as the period from the start date of radiotherapy until the date of death from any cause or date of last documented survival. In surviving cases, the last date of confirmation of survival is the date of termination. Untraceable cases are terminated on the last date of confirmed survival before the loss of follow-up. At the end of the study period, all enrolled cases are confirmed alive.
Time frame: From the start date of radiotherapy until the date of death from any cause or date of last documented survival, assessed up to approximately 31 months.
Safety (Grade and Frequency of Adverse Events)
The frequency of adverse events from all enrolled cases is tabulated by adverse event name and worst grade according to CTCAE ver.4.0. All adverse events are summarized without regard to causal relationships to the study treatment. The frequency and rate of grade 3 or higher adverse events are calculated.
Time frame: Adverse events were monitored from the start date of radiotherapy until the end of study protocol or death from any cause, and were assessed up to approximately 6 months. All-Cause Mortality was assessed up to approximately 31 months.
Local Control Rate
Analysis item: Disease control rate of irradiated target lesions. The rate of patients with a best overall response of SD or better confirmed by 180 days, starting from the start date of radiotherapy. The RECIST Guidelines Version 1.1 was used to determine overall response such as CR, PR, SD, and PD at each imaging time. If imaging is not available, the patient is considered NE.
Time frame: 6 months
| Milestone | Radiotherapy + Nivolumab |
|---|---|
| Started | 41 |
| Completed | 22 |
| Not completed | 19 |
| Withdrew: Lack of efficacy | 16 |
| Withdrew: 3 cases did not meet the criteria for nivolumab initiation. | 3 |
Analysis item: Disease control rate of non-irradiated target lesions. The rate of patients with a best overall response of stable disease (SD) or better confirmed by 180 days, starting from the start date of radiotherapy. The RECIST Guidelines Version 1.1 was used to determine overall response such as complete response (CR), partial response (PR), SD, and progressive disease (PD) at each imaging time. If imaging is not available, the patient is considered deficient (NE).
| Participants | Radiotherapy + Nivolumab |
|---|---|
| Disease Control Rate | 9 |
Overall survival is defined as the period from the start date of radiotherapy until the date of death from any cause or date of last documented survival. In surviving cases, the last date of confirmation of survival is the date of termination. Untraceable cases are terminated on the last date of confirmed survival before the loss of follow-up. At the end of the study period, all enrolled cases are confirmed alive.
| Days | Radiotherapy + Nivolumab |
|---|---|
| Median Survival Time | 230 (157 to 330) |
The frequency of adverse events from all enrolled cases is tabulated by adverse event name and worst grade according to CTCAE ver.4.0. All adverse events are summarized without regard to causal relationships to the study treatment. The frequency and rate of grade 3 or higher adverse events are calculated.
| Participants | Radiotherapy + Nivolumab |
|---|---|
| Anemia | 8 |
| Anorexia | 5 |
| Tumor pain | 3 |
| Dehydration | 2 |
| Nausea | 2 |
| Alkaline phosphatase increased | 1 |
| Blood bilirubin increased | 1 |
| Cholecystitis | 1 |
| Dyspnea | 1 |
| Febrile neutropenia | 1 |
| Fever | 1 |
| Gastric hemorrhage | 1 |
| Hyperglycemia | 1 |
| Hyperkalemia | 1 |
| Hyperuricemia | 1 |
| Hypoalbuminemia | 1 |
| Hyponatremia | 1 |
| Ileus | 1 |
| Platelet count decreased | 1 |
| Proteinuria | 1 |
| Supraventricular tachycardia | 1 |
| White blood cell decreased | 1 |
| Lung infection | 1 |
Analysis item: Disease control rate of irradiated target lesions. The rate of patients with a best overall response of SD or better confirmed by 180 days, starting from the start date of radiotherapy. The RECIST Guidelines Version 1.1 was used to determine overall response such as CR, PR, SD, and PD at each imaging time. If imaging is not available, the patient is considered NE.
| Participants | Radiotherapy + Nivolumab |
|---|---|
| Local Control Rate | 16 |
Collected over Adverse events were monitored from the start date of radiotherapy until the end of study protocol or death from any cause, and were assessed up to approximately 6 months. All-Cause Mortality was assessed up to approximately 31 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiotherapy + Nivolumab | 28/41 (68.3%) | 16/41 (39%) | 19/41 (46.3%) |
| Event | Radiotherapy + Nivolumab |
|---|---|
| AnemiaBlood and lymphatic system disorders | 8/41 |
| AnorexiaMetabolism and nutrition disorders | 5/41 |
| Tumor painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/41 |
| DehydrationMetabolism and nutrition disorders | 2/41 |
| NauseaGastrointestinal disorders | 2/41 |
| Alkaline phosphatase increasedInvestigations | 1/41 |
| Blood bilirubin increasedInvestigations | 1/41 |
| CholecystitisHepatobiliary disorders | 1/41 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/41 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/41 |
| Event | Radiotherapy + Nivolumab |
|---|---|
| FatigueGeneral disorders | 9/41 |
| Aspartate aminotransferase increasedInvestigations | 8/41 |
| HypocalcemiaMetabolism and nutrition disorders | 8/41 |
| PruritusSkin and subcutaneous tissue disorders | 6/41 |
| VomitingGastrointestinal disorders | 6/41 |
| Alanine aminotransferase increasedInvestigations | 5/41 |
| ConstipationGastrointestinal disorders | 5/41 |
| Edema limbsGeneral disorders | 5/41 |
| Peripheral sensory neuropathyNervous system disorders | 5/41 |
| Creatinine increasedInvestigations | 4/41 |
A total of 41 patients enrolled in this study were subjected to the safety analysis, and 40 patients, excluding one ineligible patient (72 years old, male), were subjected to the efficacy analysis.
| Age, Continuous(years) | Radiotherapy + Nivolumab |
|---|---|
| Median | 70 (36 to 86) |
| Sex: Female, Male(Participants) | Radiotherapy + Nivolumab |
|---|---|
| Female | 7 |
| Male | 34 |
| Race and Ethnicity Not Collected(Participants) | Radiotherapy + Nivolumab |
|---|
| Eligible patients(Participants) | Radiotherapy + Nivolumab |
|---|---|
| Count of participants | 40 |
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Fukushima Medical University