ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07462143 के लिए कोलोरेक्टल (कोलन या रेक्टल) कैंसर वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer चरण II, चरण III 700
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07462143 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन कोलोरेक्टल (कोलन या रेक्टल) कैंसर से जुड़ा हुआ है और यह एक चरण II चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 700 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 30 अप्रैल 2026 से शुरू होगा। RemeGen Co., Ltd. इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2030 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 10 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)
विस्तृत विवरण
Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
आधिकारिक शीर्षक
A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer
स्वास्थ्य स्थितियां
कोलोरेक्टल (कोलन या रेक्टल) कैंसरअन्य अध्ययन आईडी
- RC148-C303
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-04-30
अंतिम अद्यतन प्रकाशित
2026-03-10
अध्ययन की समाप्ति तिथि (अनुमानित)
2030-12-31
नामांकन (अनुमानित)
700
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
चरण III
चरण III
स्थिति
अभी भर्ती शुरू नहीं
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकExperimental Group 1 Drug: RC148 （Dose1） in combination with CAPEOX | RC148 (Dose 1) plus Capecitabine and Oxaliplatin RC148 (Dose 1) plus Capecitabine and Oxaliplatin |
प्रयोगात्मकExperimental Group 2 Drug: RC148 RC148 (Dose 2) in combination with CAPEOX | RC148 (Dose 2) plus Capecitabine and Oxaliplatin RC148 (Dose 2) plus Capecitabine and Oxaliplatin |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Objective Response Rate (ORR) | Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1 | 24 months |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Duration of Response (DoR) | Duration of Response (DoR) assessed by the investigator according to RECIST v1.1 | 24 months |
Disease Control Rate (DCR) | Disease Control Rate (DCR) assessed by the investigator according to RECIST v1.1 | 24 months |
Time to Response (TTR) | Time to Response (TTR) assessed by the investigator according to RECIST v1.1 | 24 months |
Overall Survival (OS) | OS | 36 months |
AEs/SAE | The incidence and severity of adverse events / serious adverse events | 36 months |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
- Aged 18-75 years old (including 18 years old and 75 years old).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion according to RECIST v1.1 criteria.
- Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
- Subjects must be able to provide tumor tissue samples for biomarker detection.
- Adequate bone marrow, liver, kidney, and coagulation function.
- Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.
- Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
- Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
- Subjects with brain metastases.
- Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.0.
- Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
- Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
- Subjects with acute, chronic, or symptomatic infections.
- Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
- Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
- Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
- Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
- Presence of symptomatic or intervention-requiring third-space effusions.
- Subjects with active or previously diagnosed autoimmune diseases that may recur.
- History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
- Subjects who are pregnant, lactating, or planning to become pregnant.
RemeGen Co., Ltd.अध्ययन केंद्रीय संपर्क
संपर्क: Hongfang Li, 010-65018841, [email protected]
19 1 देशों में अध्ययन स्थान
Beijing Municipality
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Chongqing Municipality
Chongqing Cancer Hospital, Chongqing, Chongqing Municipality, China
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong
Meizhou People's Hospital, Meizhou, Guangdong, China
Guangxi
Guangxi Medical University Cancer Hospital, Nanjing, Guangxi, China
Hebei
The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital, Shijiazhuang, Hebei, China
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Hubei
Tongji Medical College of Huazhong University of Science &Technology, Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
Jilin
The first hospital of Jilin University, Changchun, Jilin, China
Shanghai Municipality
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China
Shanxi
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
Sichuan
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Municipality
People's Hospital of Tianjin, Tianjin, Tianjin Municipality, China
Yunnan
Yunnan Cancer Hospital, Kunming, Yunnan, China
Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China