Trial Title:
Clinical Efficacy Study of Pucotenlimab Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer
NCT ID:
NCT06561308
Condition:
Endometrioid Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Carboplatin
Conditions: Keywords:
Neoadjuvant chemotherapy
PD-1 inhibitor(Pucotenlimab)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Carboplatin AUC=4-6 q3w , paclitaxel 175 mg/m2 q3w and Pucotenlimab iv.200mg q3w
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pucotenlimab
Description:
Pucotenlimab is administered at 200mg, q3w，intravenous infusion
Arm group label:
Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC=4-6，q3w，intravenous infusion
Arm group label:
Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
175 mg/m2，q3w，intravenous infusion, administered over 30min.
Arm group label:
Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection +
pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection
Arm group label:
Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma
Summary:
Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1
inhibitors on advanced stage III-IV endometrial cancer
Detailed description:
Conduct domestic multicenter, prospective phase II single arm clinical trials to answer
the following questions：
1. Evaluate the impact of neoadjuvant chemotherapy combined with PD-1 inhibitor on the
remission rate, surgical complications, and surgical resection rate of advanced
stage III-IV endometrial cancer;
2. Evaluate the effect of of neoadjuvant chemotherapy combined with PD-1 inhibitors on
the survival of patients with advanced III-IV endometrial cancer;
3. Exploring the changes in tumor local immune related factors and cells before and
after neoadjuvant chemotherapy and PD-1 inhibitor use, as well as the responsiveness
of different molecular subtypes of endometrial cancer to neoadjuvant therapy, and
screen for biological indicators that predict the effectiveness of PD-1 inhibitors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Endometrial cancer initially diagnosed as stage III non-operable resectable, stage
IV (FIGO, 2019 criteria) after imaging evaluation
2. Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
3. Patient age ≥18 years and ≤75 years old
4. ECOG status score of 0-1
5. tolerate surgery and radiotherapy
6. Laboratory tests: WBC ≥3.5×109/L, NEU ≥1.5×109/L, PLT ≥80×109/L, serum ≥80×109/L,
serum ≥80×109/L, serum ≥80×109/L, serum ≥80×109/L.
×109/L, serum bilirubin ≤1.5 times the high limit of normal value, transaminase ≤1.5
times the high limit of normal value, BUN ≤1.5 times the high limit of normal value.
1.5 times of the high limit of normal value, BUN, Cr≤normal value;
7. Able to follow up and good compliance;
8. Able to sign the informed consent form, including compliance with the requirements
and restrictions listed in the informed consent form and the program.
Exclusion Criteria:
1. Subjects with an active, known, or suspected autoimmune disease, or a history of an
autoimmune disease, except for: vitiligo, alopecia areata, Graves' disease,
psoriasis, or eczema that has not required systemic therapy within the last 2 years,
hypothyroidism that is asymptomatic or requires only stable doses of hormone
replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires
only stable doses of insulin replacement therapy, asthma that subsides completely in
childhood and does not require intervention in adulthood, or diseases that do not
recur in the absence of external triggers;
2. Prior treatment with immune checkpoint inhibitors, including, but not limited to,
other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatment directed
against immune co-stimulators (e.g., antibodies directed against ICOS, CD40, CD137,
GITR, OX40 targets, etc.) that target any mechanism of immune action against tumors;
3. Known hypersensitivity to any component and/or any excipient of the trial regimen;
4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (>10
mg/day of prednisone or other equivalent) within 2 weeks prior to trial dosing;
topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are
permitted;
5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g.,
thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
6. Active systemic infection requiring systemic treatment;
7. Serious infection within 4 weeks prior to the first dose, including but not limited
to complications requiring hospitalization, sepsis, or severe pneumonia;
8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis
B virus (HBV) DNA greater than 1,000 IU/mL, or patients with active hepatitis C.
Inactive HBsAg carriers, treated hepatitis B patients with stable disease (HBV DNA <
1000 IU/mL), and cured hepatitis C patients will be eligible for enrollment. HCV
antibody-positive subjects will be eligible for the study only if they have a
negative HCV RNA test;
9. Known active tuberculosis (TB), patients with suspected active TB should undergo
chest X-ray and sputum examination in conjunction with clinical signs and symptoms
for exclusion;
10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
11. Subjects with active inflammatory bowel disease or a history of such disease (e.g.,
Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable
to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting,
diarrhea, or other gastrointestinal disorders that severely interfere with drug
intake and absorption;
12. Known interstitial lung disease that is symptomatic or may interfere with detection
or treatment of immune-associated pneumonia;
13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the
first trial dose, inactivated seasonal influenza virus vaccine is permitted;
14. Patients who have received a prior allogeneic bone marrow transplant or solid organ
transplant;
15. History of primary malignant tumor within the last 5 years;
16. Subjects who have undergone major surgery (e.g., open abdomen, open chest, organ
resection, etc.) and severe trauma within 28 days prior to the first dose of
implantable infusion devices are permitted;
17. Subjects with a history of gastrointestinal perforation, gastrointestinal fistula,
or female genital fistula;
18. Uncontrolled other co-morbidities, symptoms, or medical history, including: (1)
Persons with one of the following cardiovascular diseases or cardiovascular risk
factors: myocardial infarction, unstable angina pectoris, pulmonary embolism,
acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic
attack, theor other clinically significant/required drug intervention arterial or
venous thrombosis, embolism or cerebral ischemic events; symptoms of congestive
heart failure (NYHA class III or higher) within 6 months (ii) clinically significant
bleeding symptoms or a history of significant bleeding characteristics, such as
gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis, within 1 month
prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis,
abdominal abscess, and gastrointestinal obstruction; (iv) uncontrolled pleural
effusion, pericardial effusion, or ascites requiring repeated drainage; (v)
abnormalities of hepatic or renal development, or a history of surgery;
19. Female patients who are pregnant or breastfeeding; women of childbearing age who
refuse to accept contraceptive measures during neoadjuvant immunotherapy;
20. Concurrent participation in other interventional clinical trials; participation in
observational and non-interventional clinical trials is permitted;
21. Any condition that, in the opinion of the Investigator, may result in risk in the
receipt of the study drug or that would interfere with the evaluation of the safety
of the study drug or the interpretation of the study results. In the judgment of the
Investigator, it is unlikely that Patients who, in the judgment of the Investigator,
are less likely to comply with the study steps, restrictions, and requirements shall
not be permitted to participate in this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Women's hospital school of medicine zhejiang university
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Contact:
Last name:
Hui Wang, PhD
Phone:
057189998857
Email:
wang71hui@zju.deu.cn
Start date:
September 1, 2024
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Ningbo No. 1 Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06561308
