Trial Outcomes & Findings for Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence (NCT NCT03322267)

Results Overview

From enrollment to relapse or death

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

up to 21.6 months

Results posted on

2024-12-19

Participant Flow

Among the 88 patients screened at National Taiwan University Hospital, Taipei City, Taiwan, between October 2018 and December 2022, 25 were finally included in the present study (protocol defined 24 evaluable patients according to statistical hypothesis and total 26 as considering for drop-out rate) .

Participant milestones

Participant milestones
Measure	Pembrolizumab Adjuvant cisplatin-chemoradiotherapy followed by pembrolizumab Pembrolizumab: Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)
Overall Study STARTED	25
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Adjuvant cisplatin-chemoradiotherapy followed by pembrolizumab Pembrolizumab: Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)
Overall Study Lack of Efficacy	11
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=25 Participants Adjuvant cisplatin chemoradiotherapy followed by pembrolizumab
Age, Customized Median age	62.3 years n=5 Participants
Sex/Gender, Customized Male	22 participants n=5 Participants
Sex/Gender, Customized female	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	25 participants n=5 Participants
Region of Enrollment Taiwan	25 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 21.6 months

Population: intention-to-treat

From enrollment to relapse or death

Outcome measures

Outcome measures
Measure	Pembrolizumab n=25 Participants Adjuvant cisplatin-chemoradiotherapy followed by pembrolizumab Pembrolizumab: Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)
1-year Relapse-free Survival Rate	14.3 months Interval 9.0 to 19.5

SECONDARY outcome

Timeframe: 21.6 months

from enrollment to relapse or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21.6 months

Overall survival is from enrollment to death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Recurrence-free survival is the time from enrollment to disease recurrence or the last follow-up (censored). Recurrence will be detected by regular image study (computed scan and esophagoscopy) every 3 months during the 1st to 3rd years then every 6 months during 4th and 5th years after esophagectomy. Response Evaluation Criteria in Solid Tumors 1.1 will be used for assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

OS is the time from enrollment to death of any cause or the last follow-up (censored).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

To explore the tumor tissue-based biomarkers associated with tumor recurrence.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

To explore the blood-based biomarkers associated with tumor recurrence.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab

Serious events: 5 serious events

Other events: 9 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=25 participants at risk Pembrolizumab treatment
Gastrointestinal disorders Colitis	4.0% 1/25 • I year
Blood and lymphatic system disorders Leucopenia	4.0% 1/25 • I year
Gastrointestinal disorders Pancreatitis	4.0% 1/25 • I year
Infections and infestations Infection	8.0% 2/25 • I year

Other adverse events

Other adverse events
Measure	Pembrolizumab n=25 participants at risk Pembrolizumab treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	24.0% 6/25 • I year
Infections and infestations Infection	32.0% 8/25 • I year
Gastrointestinal disorders Diarrhea	28.0% 7/25 • I year
General disorders Fatigue	20.0% 5/25 • I year
Blood and lymphatic system disorders Leucopenia	36.0% 9/25 • I year
Blood and lymphatic system disorders anemia	20.0% 5/25 • I year
Blood and lymphatic system disorders thrombocytopenia	12.0% 3/25 • I year

Additional Information

Dr Chih-Hung Hsu

National Taiwan University Hospital

Phone: +886-23123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place