Cervical cancer
Conditions
Interventions
Group one:Sintilimab combined with radiotherapy and chemotherapy
Sponsors
Anhui Cancer Hospita
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women between 18 and 70 years old; FIGO staging (2018) stage IV cervical cancer patients; (1) Histopathologically confirmed: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; 2. Karnofsky score >= 70; ECOG score 0-2; 3. There is a possibility of follow-up; 4. Heart function, liver and kidney function, and thyroid function are normal; 5. The patient signs an informed consent form; 6. The patient must not have received any definite cervical cancer surgery, radiotherapy or systemic treatment before, and must not have received immunotherapy; 7. The investigator assessed the acceptance of radiotherapy, chemotherapy and immunotherapy; 8. At least one lesion (never received radiotherapy) at baseline meets the RECIST 1.1 target lesion standard. Tumor evaluation must be performed by CT scan or MRI within 28 days before randomization.
Exclusion criteria
Exclusion criteria: 1. Poor compliance; 2. The withdrawal time of other clinical trial drugs is less than 4 weeks; 3. Have a history of allogeneic organ transplantation; 4. Active or previously recorded autoimmune or inflammatory diseases (including but not limited to inflammatory bowel disease [such as colitis or Crohns disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis complex Signs, Wegener syndrome [granulomatous polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this standard: (1) Patients with vitiligo or alopecia; (2) Patients with hypothyroidism (such as after suffering from Hashimoto's syndrome) and stable disease after receiving hormone replacement therapy; (3) Patients with any chronic skin diseases that do not require systemic treatment; (4) Patients without active disease in the past 5 years can be included in the study after discussing with the study doctor; (5) Patients with celiac disease who rely solely on diet control; 5. Uncontrolled comorbid diseases, including but not limited to: persistent or active infections, active interstitial lung disease (ILD), severe chronic gastrointestinal diseases accompanied by diarrhea, or may limit the requirements for research Compliance, psychiatric/social problem conditions that lead to a significant increase in the risk of AEs or affect the subjects ability to provide written informed consent; 6. History of other primary malignant tumors, except for the following conditions: malignant tumors that have been cured, and there is no known active disease >= 5 years before the first administration of IP, and the potential risk of recurrence is low; 7. History of active primary immunodeficiency; 8. Active infections include pulmonary tuberculosis (clinical evaluation includes clinical history, physical examination and imaging findings, and tuberculosis examination based on local operations), hepatitis B (known to be positive for HBV HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV, HIV 1/2 antibody positive). Patients who have previously suffered from HBV infection or who have been cured of HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and the absence of HBsAg) are eligible. Patients with positive HCV antibodies can participate in this study only when the polymerase chain reaction (PCR) shows negative HCV RNA; 9. Using Fridericia formula (QTcF) according to 3 ECG examination results (within 15 minutes, the interval is 5 minutes) calculated average QT interval of heart rate correction >= 470 ms; 10. Known to have allergic reactions or hypersensitivity reactions to any research drug or any of its excipients; 11. Past history of bladder fistula, vaginal fistula or rectal fistula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxic side effects;Quality of Life; | — |
Countries
China
Contacts
Public ContactLiu Yunqin
Anhui Cancer Hospital
Outcome results
None listed