Clinical Trials List
Protocol NumberMS914001_0002
NCT Number(ClinicalTrials.gov Identfier)NCT07549412
Not yet recruiting
2026-07-01 - 2029-05-31
Phase III
Not yet recruiting1
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/08
Investigators and Locations
Co-Principal Investigator
- 謝明皓 Division of Colorectal Surgery
- 黃晟瑋 Division of Colorectal Surgery
- Hwei-Ming Wang Division of Colorectal Surgery
- 陳柏勳 Division of Colorectal Surgery
- Tzu-Liang Chen Division of Colorectal Surgery
- 蔡嘉祐 Division of Colorectal Surgery
- 蔡元耀 Division of Colorectal Surgery
- 陳奕彰 Division of Colorectal Surgery
Co-Principal Investigator
Co-Principal Investigator
Co-Principal Investigator
Co-Principal Investigator
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Metastatic Colorectal Cancer
Objectives
本試驗旨在處理先前曾接受 irinotecan、oxaliplatin、fluoropyrimidine 和 bevacizumab 治療之轉移性大腸直腸癌 (mCRC) 參與者的未獲滿足醫療需求，方法為證明 precemtabart tocentecan (Precem-TcT) 作為單一藥物或 Precem-TcT 併用 bevacizumab 相較於 trifluoride/tipiracil (FTD-TPI) 加上 bevacizumab 可延長整體存活期 (OS)。
Test Drug
注射用凍晶粉末
膜衣錠
靜脈點滴注射劑
膜衣錠
靜脈點滴注射劑
Active Ingredient
precemtabart tocentecan (Precem-TcT)
Trifluridine/Tipiracil hydrochloride
BEVACIZUMAB
Trifluridine/Tipiracil hydrochloride
BEVACIZUMAB
Dosage Form
048
116
242
116
242
Dosage
80 mg
15 mg/6.14 mg
100 mg/4 mL
15 mg/6.14 mg
100 mg/4 mL
Endpoints
整體存活期 (OS)定義為從隨機分配之日起至死亡為止所經過的時間。
Inclution Criteria
Inclusion Criteria:
Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
Other protocol defined inclusion criteria may apply
Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
Other protocol defined inclusion criteria may apply
Exclusion Criteria
Exclusion Criteria:
If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
Participant has a history of additional malignancy within 3 years before randomization
Participants with known brain metastases
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments
Other protocol defined exclusion criteria may apply
If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
Participant has a history of additional malignancy within 3 years before randomization
Participants with known brain metastases
Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments
Other protocol defined exclusion criteria may apply
The Estimated Number of Participants
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Taiwan
59 participants
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Global
1020 participants
