ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07491159 के लिए कोलो-रेक्टल कैंसर वर्तमान में सक्रिय, भर्ती 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
खोज पर वापस जाएँ
तियानजिन मेडिकल विश्वविद्यालयFruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study चरण I, चरण II 106 इम्यूनोथेरेपी लक्षित थेरेपी संयोजन थेरेपी कुल उत्तरजीविता
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 NCT07491159 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन कोलो-रेक्टल कैंसर से जुड़ा हुआ है और यह एक चरण I चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 1 जुलाई 2023 को हुई थी, और इसमें कुल 106 प्रतिभागियों के नामांकन की योजना है। तियानजिन मेडिकल विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 दिसंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 24 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Colorectal cancer (CRC) is the fourth leading cause of cancer death worldwide, claiming approximately 900,000 lives annually. In China, CRC has become one of the top three most common cancers, with about 555,000 new cases and 286,000 deaths reported in 2020.
For patients with advanced metastatic colorectal cancer (mCRC), chemotherapy remains the main treatment approach. While first and second-line treatments have im...
और दिखाएँआधिकारिक शीर्षक
Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential Trifluridine/Tipiracil(TAS-102) Based Regimen in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study
स्वास्थ्य स्थितियां
कोलो-रेक्टल कैंसरअन्य अध्ययन आईडी
- CRC later-line
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-07-01
अंतिम अद्यतन प्रकाशित
2026-03-24
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-12-30
नामांकन (अनुमानित)
106
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
चरण II
चरण II
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
fruquintinib
Trifluridine/tipiracil
Microsatellite Stable
metastatic colorectal cancer
Trifluridine/tipiracil
Microsatellite Stable
metastatic colorectal cancer
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
गैर-यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकFruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil | Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil |
प्रयोगात्मकFruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab | Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
RP2D | Recommended phase 2 dose | From enrollment to the end of treatment at 4 week |
Overall Survival (OS) | Time from randomization/enrollment to death from any cause | Up to 36 months |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Progress-free Survival (PFS) | Time from randomization/enrollment to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first | Assessed every 8 weeks, up to 12 months |
Objective Response Rate (ORR) | The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Tumor assessments performed at baseline, then every 8 weeks (±7 days) from the date of first dose until radiographic disease progression or death, assessed up to approximately 12 months |
Duration of Response (DoR) | Time from first documented response (CR/PR) to disease progression or death | Up to 12 months |
Incidence of AEs | Number and percentage of participants experiencing adverse events graded by NCI-CTCAE v5.0 | by NCI-CTCAE v5.0. From first dose up to 30 days after last dose |
Incidence of SAEs | Number and percentage of participants experiencing serious adverse events | From informed consent up to 30 days after last dose |
Number of participants with Laboratory abnormalities | Incidence of clinically significant laboratory parameter changes per NCI-CTCAE v5.0 | From baseline up to 30 days after last dose |
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
- Fully informed about this study and voluntarily signed the informed consent form;
- Age 18-75 years (inclusive);
- Histologically confirmed unresectable metastatic colorectal cancer;
- Confirmed pMMR (proficient mismatch repair) status without protein loss, as determined by:PCR testing showing microsatellite stable (MSS) or low microsatellite instability (MSI-L), OR Immunohistochemistry (IHC) demonstrating intact DNA mismatch repair (MMR) protein expression (including MLH1, MSH2, MSH6, and PMS2);
- Failed or intolerant to two prior lines of standard systemic therapy for metastatic colorectal cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Body Mass Index (BMI) ≥18 kg/m²;
- Life expectancy ≥3 months;
- Adequate organ function as defined below (no blood components or growth factors allowed within 14 days prior to enrollment):
- Hematologic Function:
Absolute neutrophil count (ANC) ≥1.5×10⁹/L; White blood cell count (WBC) ≥4.0×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; -Hepatic Function: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN;
-Renal Function: Blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN; Creatinine clearance (CCr) ≥50 mL/min;
-Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50%; QT interval corrected by Fridericia's formula (QTcF) <470 ms;
-Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Women of childbearing potential must use effective contraception;
- Good compliance and willing to cooperate with follow-up visits.
- Unable to comply with the study protocol or study procedures;
- Prior treatment with TAS-102 (trifluridine/tipiracil);
- Prior treatment with VEGFR inhibitors;
- Prior treatment with immune checkpoint inhibitors;
- Concurrent use of any other investigational drugs, or participation in another clinical trial with investigational drug treatment within 4 weeks prior to enrollment;
- Vaccination with inactivated vaccines within 4 weeks prior to enrollment or planned vaccination during the study period;
- Major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment;
- Blood transfusion, blood products, or hematopoietic factors (such as albumin, granulocyte colony-stimulating factor \[G-CSF\], etc.) within 28 days prior to enrollment;
- Alcohol or drug abuse within 4 weeks prior to enrollment;
- Any factors affecting oral drug administration;
- Concurrent presence of any of the following conditions:
- Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure;
- Uncontrolled severe concurrent infection resulting in disability;
- Proteinuria ≥2+ (1.0 g/24 h);
- Evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity;
- Arterial/venous thromboembolic events within 12 months prior to first treatment, such as cerebrovascular accident (including transient ischemic attack), etc.;
- Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass grafting (CABG) within 6 months prior to first treatment;
- Fracture or long-term unhealed wounds;
- Coagulation dysfunction, bleeding tendency, or currently receiving anticoagulant therapy;
- Evidence of central nervous system (CNS) metastasis, or accompanied by severe malignant pleural effusion or ascites;
- Other malignancies within 5 years prior to enrollment, except for basal cell or squamous cell carcinoma of the skin after curative surgery, or carcinoma in situ of the cervix;
- Active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
- Prior allogeneic bone marrow transplantation or organ transplantation;
- Known hypersensitivity to study drugs or any of their excipients;
- Unresolved toxicities greater than CTCAE v5.0 Grade 1 from prior anti-cancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity ≤Grade 2;
- Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, provides reasonable suspicion that the patient has a condition unsuitable for the use of the study drug (e.g., epileptic seizures requiring treatment), or that would affect the interpretation of study results, or would place the patient at high risk;
- Pregnant or breastfeeding women;
- Any patient deemed unsuitable for enrollment in this study by the investigator.
तियानजिन मेडिकल विश्वविद्यालय378 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिएकोई संपर्क डेटा नहीं।
1 1 देशों में अध्ययन स्थान
Tianjin Municipality
Tianjin Cancer Hospital, Tianjin, Tianjin Municipality, 300202, China