Clinical Trials List
Protocol NumberC6461016
NCT Number(ClinicalTrials.gov Identfier)NCT07392892
Not yet recruiting
2026-07-24 - 2032-07-21
Phase II/III
Not yet recruiting3
A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/08/25
Investigators and Locations
Co-Principal Investigator
- Hung-Yuan Yu 無
- 唐振育 無
- Yi-Ping Hung 無
- 邱乃祈 無
- Yun-Cheng Hsieh 無
- 姜乃榕 無
- San-Chi Chen 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 李佳真 無
- JHE-CYUAN GUO 無
- Chih-Hung Hsu 無
- 郭弘揚 無
- 陳國興 無
- 黃柏翔 無
- Ying-Chun Shen 無
- SUNG-HSIN KUO 無
- 梁逸歆 無
- 莊建淮 無
- 張端瑩 無
- Ann-Lii Cheng 無
- 陳柏邑 無
- 陳敬左 無
- TA-CHEN HUANG 無
- 林宗哲 無
- 呂理駿 無
- TSUNG-HAO LIU 無
- YU-YUN SHAO 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Chih-Chieh Yen
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
Objectives
評估 PF-08634404 併用化療是否可改善先前未接受治療之 LA/m 胃癌 (GC)、胃食道交界 GEJ) 腺癌或食道腺癌 (EAC)參與者的臨床結果。
Test Drug
注射劑
注射劑
注射劑
注射劑
錠劑
注射劑
錠劑
注射劑
注射劑
注射劑
錠劑
注射劑
錠劑
Active Ingredient
PF-08634404
FLUOROURACIL
CALCIUM FOLINATE (EQ TO FOLINIC ACID)
OXALIPLATIN
CAPECITABINE
FLUOROURACIL
CALCIUM FOLINATE (EQ TO FOLINIC ACID)
OXALIPLATIN
CAPECITABINE
Dosage Form
270
270
270
270
110
270
110
270
270
270
110
270
110
Dosage
200mg/10mL
2500mg/50mL
300mg/30mL
100 mg/20mL
500mg
1000mg/20mL
150mg
2500mg/50mL
300mg/30mL
100 mg/20mL
500mg
1000mg/20mL
150mg
Endpoints
Ph2
• 由試驗主持人使用實體腫瘤反應評估標準 (RECIST) 評估的確認客觀緩解率 (ORR)
• 不良事件 (AE)，依類型、頻率、嚴重程度 (依美國國家癌症機構 [NCI] 不良事件共同術語標準 [CTCAE] 版本 5.0 分級)、時間點、嚴重性和與試驗介入治療的關係描述特性
Ph3
• 由 BICR 使用 RECIST 1.1 評估的 PFS
• OS
• 由試驗主持人使用實體腫瘤反應評估標準 (RECIST) 評估的確認客觀緩解率 (ORR)
• 不良事件 (AE)，依類型、頻率、嚴重程度 (依美國國家癌症機構 [NCI] 不良事件共同術語標準 [CTCAE] 版本 5.0 分級)、時間點、嚴重性和與試驗介入治療的關係描述特性
Ph3
• 由 BICR 使用 RECIST 1.1 評估的 PFS
• OS
Inclution Criteria
Inclusion Criteria:
Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
Evidence of locally advanced or metastatic disease.
Eastern Cooperative Oncology Group performance status (ECOG) 0-1
No prior systemic therapy for advanced or metastatic disease.
Adequate hepatic, liver, and renal function
HER-2 negative status based on local testing
PD-L1 positive status based on local testing
Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
Evidence of locally advanced or metastatic disease.
Eastern Cooperative Oncology Group performance status (ECOG) 0-1
No prior systemic therapy for advanced or metastatic disease.
Adequate hepatic, liver, and renal function
HER-2 negative status based on local testing
PD-L1 positive status based on local testing
Exclusion Criteria
Exclusion Criteria:
Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression
Clinically significant risk of hemorrhage or fistula
Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression
Clinically significant risk of hemorrhage or fistula
Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
The Estimated Number of Participants
-
Taiwan
9 participants
-
Global
40 participants
