This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. Hypofractionation which represented by stereotactic body radiation therapy (SBRT) is a technique that delivers higher daily doses of radiation over a shorter period of time. This trial will also observe the index which can influencing the curative effect of hyperfractionated radiotherapy combined with immunotherapy.
This trial is a prospective, observational, single-center, single-arm clinical research. This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the first immunotherapy, hypofractionated radiotherapy(SABR) with tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed. And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin. Generally, the radiotherapy will end before the fourth immunotherapy. During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 60 study participants.
Study Type
OBSERVATIONAL
Enrollment
60
Immunotherapy combined with hyperfractionated radiotherapy
Progression free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause, whichever comes first.
Time frame: 2 years
Subject safety
Number of Adverse Events using NCI CTCAE 5.0
Time frame: 2 years
Overall Survival(OS)
Overall survival, defined from the date of first treatment to the date of death due to any cause.
Time frame: 2 years
Objective response rate(ORR)
Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
Time frame: 2 years
Disease control rate(DCR)
Disease control rate, which is defined as the proportion of subjects who achieve a response of complete response,partial response and stable disease (PR+CR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria
Time frame: 2 years
Local Control Rate
Local Control Rate, which is defined as the proportion of subjects who achieve a response of remission and stable disease (PR+CR+SD) evaluated by RECIST 1.1 after radiotherapy
Time frame: 2 years
Distant metastasis-free survival(DMFS)
Distant metastasis-free survival(DMFS), defined from the date of first treatment to the date of the appearance of distant metastasis or death due to any cause.
Time frame: 2 years
Response rate of lesions that did not receive radiotherapy
Response rate of lesions that did not receive radiotherapy, which is defined as the percentage of the number of cases with tumors that have not received radiotherapy in remission and stable disease (PR+CR+SD) in the total number of evaluable cases using the RECIST 1.1 criteria.
Time frame: 2 years
Quality of Life: EORTC QLQ-C30 questionnaire
Quality of life, which will be evaluated using the EORTC(The European Organization for Reasearch and Treatment of Cancer) QLQ-C30(Quality of Life Questionnare-Core 30) questionnaire. The questionnaire contains 30 items. Items 29 and 30 are divided into seven levels, which are counted from 1 to 7 points, 1 is very poor, and 7 is very good. Other items are divided into 4 levels: no at all, a little bit, a lot, and very, and they are directly rated from 1 to 4 points
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.