Cervical Cancer
Conditions
Interventions
1: recombinant human endostatin
Sponsors
Sichuan Cancer Hospital & Sichuan Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathology confirmed as cervical squamous cell carcinoma; 2. FIGO stage IIB-IIIB; 3. Pelvic nuclear magnetic resonance confirmed lymph node diameter greater than 1 cm, or PET / CT confirmed pelvic lymph node metastasis;or bulky tumors with diameter more than 4cm; 4. No distant metastasis; 5. Aged 18-75 years old; 6.Karnofsky physical condition score> = 70; 7. No chemotherapy or any other anti-tumor therapy before enrollment; 8. Able to follow the program during the study period; 9. Signed a written informed consent.;Inclusion criteria: 1. Pathology confirmed as cervical squamous cell carcinoma; 2. FIGO stage IIB-IIIB; 3. Pelvic nuclear magnetic resonance confirmed lymph node diameter greater than 1 cm, or PET / CT confirmed pelvic lymph node metastasis;or bulky tumors with diameter more than 4cm; 4. No distant metastasis; 5. Aged 18-75 years old; 6.Karnofsky physical condition score> = 70; 7. No chemotherapy or any other anti-tumor therapy before enrollment; 8. Able to follow the program during the study period; 9. Signed a written informed consent.;Inclusion criteria: 1. Pathology confirmed as cervical squamous cell carcinoma; 2. FIGO stage IIB-IIIB; 3. Pelvic nuclear magnetic resonance confirmed lymph node diameter greater than 1 cm, or PET / CT confirmed pelvic lymph node metastasis;or bulky tumors with diameter more than 4cm; 4. No distant metastasis; 5. Aged 18-75 years old; 6.Karnofsky physical condition score> = 70; 7. No chemotherapy or any other anti-tumor therapy before enrollment; 8. Able to follow the program during the study period; 9. Signed a written informed consent.;Inclusion criteria: 1. Pathology confirmed as cervical squamous cell carcinoma; 2. FIGO stage IIB-IIIB; 3. Pelvic nuclear magnetic resonance confirmed lymph node diameter greater than 1 cm, or PET / CT confirmed pelvic lymph node metastasis;or bulky tumors with diameter more than 4cm; 4. No distant metastasis; 5. Aged 18-75 years old; 6.Karnofsky physical condition score> = 70; 7. No chemotherapy or any other anti-tumor therapy before enrollment; 8. Able to follow the program during the study period; 9. Signed a written informed consent.;Inclusion criteria: 1. Pathology confirmed as cervical squamous cell carcinoma; 2. FIGO stage IIB-IIIB; 3. Pelvic nuclear magnetic resonance confirmed lymph node diameter greater than 1 cm, or PET / CT confirmed pelvic lymph node metastasis;or bulky tumors with diameter more than 4cm; 4. No distant metastasis; 5. Aged 18-75 years old; 6.Karnofsky physical condition score> = 70; 7. No chemotherapy or any other anti-tumor therapy before enrollment; 8. Able to follow the program during the study period; 9. Signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. pregnant or breastfeeding woman; 2. During past 5 years diagnosed with malignant disease, except for cured skin cancer; 3. uncontrolled history of epilepsy, central nervous system disease, or a history of mental disorders, and the investigator judges that their clinical severity may interfere with the signing of informed consent or the compliance of patients with oral medication; 4. Serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) II or more severe congestive heart failure or severe need for drug intervention in arrhythmias, or clinical The diagnosis of heart valve disease, or the last 12 months with a history of myocardial infarction or thrombosis, refractory hypertension history; 5. Organ transplantation requires immunosuppressive therapy; 6. Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 7. The baseline blood and biochemical test did not meet the following criteria: hemoglobin =90g/L; neutrophil absolute count (ANC) =1.5×10^9/L; platelet =100 × 10^9/2.5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin = 30g/L; 8. Allergy to any study ingredient.;Exclusion criteria: 1. pregnant or breastfeeding woman; 2. During past 5 years diagnosed with malignant disease, except for cured skin cancer; 3. uncontrolled history of epilepsy, central nervous system disease, or a history of mental disorders, and the investigator judges that their clinical severity may interfere with the signing of informed consent or the compliance of patients with oral medication; 4. Serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) II or more severe congestive heart failure or severe need for drug intervention in arrhythmias, or clinical The diagnosis of heart valve disease, or the last 12 months with a history of myocardial infarction or thrombosis, refractory hypertension history; 5. Organ transplantation requires immunosuppressive therapy; 6. Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 7. The baseline blood and biochemical test did not meet the following criteria: hemoglobin =90g/L; neutrophil absolute count (ANC) =1.5×10^9/L; platelet =100 × 10^9/2.5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin = 30g/L; 8. Allergy to any study ingredient.;Exclusion criteria: 1. pregnant or breastfeeding woman; 2. During past 5 years diagnosed with malignant disease, except for cured skin cancer; 3. uncontrolled history of epilepsy, central nervous system disease, or a history of mental disorders, and the investigator judges that their clinical severity may interfere with the signing of informed consent or the compliance of patients with oral medication; 4. Serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) II or more severe congestive heart failure or severe need for drug intervention in arrhythmias, or clinical The diagnosis of heart valve disease, or the last 12 months with a history of myocardial infarction or thrombosis, refractory hypertension history; 5. Organ transplantation requires immunosuppressive therapy; 6. Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 7. The baseline blood and biochemical test did not meet the following criteria: hemoglobin =90g/L; neutrophil absolute count (ANC) =1.5×10^9/L; platelet =100 × 10^9/2.5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin = 30g/L; 8. Allergy to any study ingredient.;Exclusion criteria: 1. pregnant or breastfeeding woman; 2. During past 5 years diagnosed with malignant disease, except for cured skin cancer; 3. uncontrolled history of epilepsy, central nervous system disease, or a history of mental disorders, and the investigator judges that their clinical severity may interfere with the signing of informed consent or the compliance of patients with oral medication; 4. Serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) II or more severe congestive heart failure or severe need for drug intervention in arrhythmias, or clinical The diagnosis of heart valve disease, or the last 12 months with a history of myocardial infarction or thrombosis, refractory hypertension history; 5. Organ transplantation requires immunosuppressive therapy; 6. Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 7. The baseline blood and biochemical test did not meet the following criteria: hemoglobin =90g/L; neutrophil absolute count (ANC) =1.5×10^9/L; platelet =100 × 10^9/2.5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin = 30g/L; 8. Allergy to any study ingredient.;Exclusion criteria: 1. pregnant or breastfeeding woman; 2. During past 5 years diagnosed with malignant disease, except for cured skin cancer; 3. uncontrolled history of epilepsy, central nervous system disease, or a history of mental disorders, and the investigator judges that their clinical severity may interfere with the signing of informed consent or the compliance of patients with oral medication; 4. Serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) II or more severe congestive heart failure or severe need for drug intervention in arrhythmias, or clinical The diagnosis of heart valve disease, or the last 12 months with a history of myocardial infarction or thrombosis, refractory hypertension history; 5. Organ transplantation requires immunosuppressive therapy; 6. Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 7. The baseline blood and biochemical test did not meet the following criteria: hemoglobin =90g/L; neutrophil absolute count (ANC) =1.5×10^9/L; platelet =100 × 10^9/2.5 times the normal upper limit; ALP = 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin = 30g/L; 8. Allergy to any study ingredient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Serious Adverse Event;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control;Disease free survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactJialin Yang;Jialin Yang;Jialin Yang;Jialin Yang;Jialin Yang ;;;;
Sichuan Cancer Hospital & Sichuan Cancer Center;Sichuan Cancer Hospital & Sichuan Cancer Center;Sichuan Cancer Hospital & Sichuan Cancer Center;Sichuan Cancer Hospital & Sichuan Cancer Center;Sichuan Cancer Hospital & Sichuan Cancer Center
Outcome results
None listed