Gyenecological cancer
Conditions
Interventions
First line chemotherapy:paclitaxel plus cisplatin or carboplatin with or without Bevacizumab
Chemotherapy combined with PD-1 checkpoint inhibitor:paclitaxel plus cisplatin or carboplatin + PD-1 checkpoint inhibitor with or without Bevacizumab
First line chemotherapy combined with SBRT:paclitaxel plus cisplatin or carboplatin with or without Bevacizumab, combined oligo-metastasis SBRT
First line chemotherapy with PD-1 checkpoint inhibitor combined with SBRT:paclitaxel plus cisplatin or carboplatin+PD-1 checkpoint inhibitor with or without Bevacizumab, combined oligo-metastasis SBRT
Sponsors
Shanghai First Maternity and Infant Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged between 18 and 60 years; 2. Gynecologic cancer (including primary uterine, cervix, ovary, fallopian, vagina and vulva) response to platinum based first-line chemotherapy with or without Bevacizumab; 3. Histologic confirmation of primary tumor either squamous cancer, adenocarcinoma or squamous-adeno carcinoma. Primary tumor being under control after initial surgery or definitive radiotherapy; 4. Performance score of 0 to 1; 5. With histologic confirmation of metastasis lesion (at least one site); 6. At least one site of measurable target lesion after first line chemotherapy according to standard of RECIST v1.1 7. Confirmed as oligo metastasis status after first line chemotherapy as follow: less than five metastases involving less than three organs. Less than three metastasis involving single organ; 8. The maximum size is 5 cm for oligo metastasis as target of SBRT; 9. Adequate cardio-respiratory and hematological reserves as follow: absolute white cell count >=3.5x10^9/L; absolute neutrophil count >=1.5x10^9/L; platelet count >=100x10^9/L; Hb >=90g/L; 10. Adequate liver and renal reserves as follow: TBIL<=1.5 ULN; ALTAST<=2.5 ULN; Cr<=1.5 ULN; 11. With at least six months of life expectancy; 12. Negative pregnant test; 13. Signed written informed consent prior to study entry.
Exclusion criteria
Exclusion criteria: 1. Autoimmune disease(s), such as SLE, other immune disease requiring immune inhibitor prescription; 2. Active infectious disease with bacteria or virus, including HBV, HCV, HIV, etc; 3. Previous radiotherapy within three years concerning the target region of SBRT; 4. Plan to receive PARP inhibitor according to BRCA gene mutation; 5. Severe organ dysfunction, such as live or renal failure, myocardial infarction, sever cardio-diseases in the past six months, or existing high risk of bleeding; 6. Clinically or pathologically diagnosis of peritoneum metastasis with gastrointestinal symptom; 7. Contraindications for chemotherapy and/or radiotherapy; 8. Plan to receive salvage surgery for oligo metastasis; 9. Tend to receive brachytherapy for vaginal cuff recurrence; 10. Symptomatic meningeal metastases; 11. Confirmed with severe psychological disease; 12. Allergic to agent(s) of treatment regimens such as paclitaxel or immune checkpoint inhibitor; 13)Confirmed with synchronous malignancy; 14. Received anti-cancer treatment other than regimen of present protocol, or participate in other clinical researches; 15. Intolerant of simulation process or required active breath control; 16. Women with pregnancy or breast-feeding status; 17. Unsuitable medical conditions for the present trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival at two years;Overall survival at two years;Free from distant metastasis;Acute/late toxicity;Quality of life; | — |
Countries
China
Contacts
Public ContactHu Qunchao
Shanghai First Maternity and Infant Hospital
Outcome results
None listed