बीटा
ट्रायल रडार AI
क्लिनिकल ट्रायल NCT06953843 के लिए EGFR/ALK उत्परिवर्तन के बिना NSCLC चरण IV वर्तमान में भर्ती जारी 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

Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases चरण II 366 इम्यूनोथेरेपी

भर्ती जारी
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 NCT06953843 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन EGFR/ALK उत्परिवर्तन के बिना NSCLC चरण IV से जुड़ा हुआ है और यह एक चरण II हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 9 जुलाई 2025 को हुई थी, और इसमें कुल 366 प्रतिभागियों के नामांकन की योजना है। Xinqiao Hospital of Chongqing इस परीक्षण का नेतृत्व कर रहे हैं और इसके 31 दिसंबर 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 14 जुलाई 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with...और दिखाएँ
आधिकारिक शीर्षक

An Umbrella Trial of Combining Different Radiotherapy Fractionation Patterns With Immunotherapy for Multiple Metastases of Non-Small Cell Lung Cancer

स्वास्थ्य स्थितियां
EGFR/ALK उत्परिवर्तन के बिना NSCLC चरण IV
अन्य अध्ययन आईडी
  • XQonc-023
NCT नंबर
NCT06953843
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-07-09
अंतिम अद्यतन प्रकाशित
2025-07-14
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-12-31
नामांकन (अनुमानित)
366
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
गैर-यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकGroup A
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
प्रयोगात्मकGroup B
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.
प्रयोगात्मकGroup C
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.
प्रयोगात्मकGroup D
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.
प्रयोगात्मकGroup E
Benmelstobart combined with chemotherapy
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.
प्रयोगात्मकGroup F
Benmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
The remission rate of abscopal lesions
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
PFS
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
OS
To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival
up to 5 years
AE
The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years
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

  • Patient must meet all of the following inclusion criteria to be enrolled in this study:

    1. Non-small cell lung cancer confirmed by pathological histology.
    2. More than 3 metastatic lesions.
    3. No brain metastases or stable lesions.
    4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).
    5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months.
    6. Age between 18 and 75 years old.
    7. Assessment by PET-CT (including FDG and FMISO, not mandatory).
    8. No contraindications to immunotherapy and radiotherapy.
    9. Signed the informed consent form.

  • Patients with any of the following criteria are not eligible for enrollment in this study:

    1. Those with severe dysfunction of important vital organs (heart, liver, kidney).
    2. Those accompanied by other malignant tumors.
    3. Uncontrolled heart diseases or myocardial infarction within the past 6 months.
    4. Those with a history of mental illness.
    5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Xinqiao Hospital of Chongqing logoXinqiao Hospital of Chongqing
अध्ययन उत्तरदायी पक्ष
Jianguo Sun, मुख्य अन्वेषक, Prof, Xinqiao Hospital of Chongqing
अध्ययन केंद्रीय संपर्क
संपर्क: Jianguo Sun, MD, 86-13983155736, [email protected]
1 1 देशों में अध्ययन स्थान

Chongqing Municipality

the second affiliated hospital of Army medical university, Chongqing, Chongqing Municipality, 400037, China
jianguo Sun, Phd, संपर्क, 023-68774490, [email protected]
भर्ती जारी