Endometrioid Endometrial CancerPhase 2NCT06561308
Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer
A Phase 2 study testing Camrelizumab, Carboplatin and Paclitaxel in people with Endometrioid Endometrial Cancer, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrioid Endometrial Cancer
- What is being tested?
- Camrelizumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation
- Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
- Patient age ≥18 years and ≤75 years old
- ECOG status score of 0-1
- tolerate surgery and systemic therapy
- 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.
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- ×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;
- Able to follow up and good compliance;
- Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and the program.
Who cannot join
- 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;
- 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;
- Known hypersensitivity to any component and/or any excipient of the trial regimen;
- 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;
- Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
- Active systemic infection requiring systemic treatment;
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- Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;
- 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;
- 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;
- Immunodeficiency or human immunodeficiency virus (HIV antibody positive);
- 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;
- Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;
- Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;
- Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;
- History of primary malignant tumor within the last 5 years;
- 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;
- Subjects with a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;
- 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;
- Female patients who are pregnant or breastfeeding; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;
- Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's hospital school of medicine zhejiang university
Hangzhou, Zhejiang, 310000
Yang Li, PhD, 86-15858223899, li_yang@zju.edu.cn
About this study
Official title: A Single-arm, Multicenter Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer in Clinical Efficacy
Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer
Read the detailed description
Conduct domestic multicenter, prospective phase II single arm clinical trials to answer the following questions：
- Evaluate the impact of neoadjuvant chemotherapy combined with camrelizumab on the remission rate, surgical complications, and surgical resection rate of advanced stage III-IV endometrial cancer;
- Evaluate the effect of of neoadjuvant chemotherapy combined with camrelizumab on the survival of patients with advanced III-IV endometrial cancer;
- Exploring the changes in tumor local immune related factors and cells before and after neoadjuvant chemotherapy and camrelizumab use, as well as the responsiveness of different molecular subtypes of endometrial cancer to neoadjuvant therapy,.
- Conditions
- Endometrioid Endometrial Cancer
- Being tested
- Camrelizumab, Carboplatin, Paclitaxel, Surgery
- Keywords
- Neoadjuvant chemotherapy, PD-1 inhibitor (Camrelizumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab is administered at 200mg, q3w，intravenous infusion
CarboplatinDrug
AUC=5，q3w，intravenous infusion
PaclitaxelDrug
175 mg/m2，q3w，intravenous infusion, administered over 30min.
SurgeryProcedure or surgery
Transabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma | Experimental | Patients with advanced endometrial cancer were enrolled for 2 or 3 cycles of neoadjuvant chemotherapy in combination with camrelizumab, with imaging to assess efficacy; intermittent subtractive surgery (transabdominal hysterectomy + bilateral adnexectomies + pelvic lymph node dissection + pelvic and abdominal tumors resections +/- para-abdominal aortic lymph node dissection) was performed in patients with complete remissions (CR)/partial remissions (PR), and continued with 3 or 4 cycles of neoadjuvant chemotherapy in combination with camrelizumab, ensuring that all patients receive a total of 6 cycles. Receives: Drug: Camrelizumab; Drug: Carboplatin; Drug: Paclitaxel; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
Measured: At the end of the patient's treatment, up to 1 years.
Secondary outcomes (5)
Surgical complication rate
intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries, as defined by the need for suture repair; occlusive nerve injuries, as defined by complete severance; and vascular injuries, as defined by the need to document the site of injury. Postoperative complications included: ureteral/bladder/rectal/vaginal fistula, internal hemorrhage, pelvic infection, lymphocyst, lymphatic fistula, lower extremity edema, lower extremity venous thrombosis, urinary retention, nerve injury, and bowel obstruction.
Measured: During and after the surgery, up to 2 years.
Adverse Event
Adverse Effects of immunotherapy and chemotherapy
Measured: during the treatment, up to 5 years.
Remission rate (%) as assessed by RECIST 1.1 criteria
Subjects were assessed for complete and partial remission rates according to RECIST 1.1 criteria
Measured: At the end of the patient's treatment, up to 1 years.
Event-free survival (EFS)
the time between the date of surgery to any documented tumor progression, recurrence, or death from any cause; the analysis of EFS includes the results of tumor evaluations during the study treatment and follow-up periods. If a patient had several indicators of PD or recurrence, the EFS analysis was performed using the indicator that appeared first; PD, recurrence, or death were considered to have reached the study endpoint; patients who were treated with other systemic or antitumor therapies directed at the target lesion of observation were also considered to be in PD; for patients who did not have PD, recurrence, or death at the end of the study, the time when the patient's failure to have a recurrence was last obtained was used as the time to censor the data.
Measured: Until the end of the 3-year follow-up period, up to 5 years.
Overall survival (OS)
the time from the start of the time from the date of enrollment to death from any cause
Measured: Until the end of the 3-year follow-up period, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Carboplatin AUC=5 q3w , paclitaxel 175 mg/m2 q3w and Camrelizumab iv.200mg q3w
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Tongji Hospital, Qilu Hospital of Shandong University, Anhui Provincial Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Henan Provincial People's Hospital, Hunan Cancer Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
- Investigators
- Hui Wang, PHD, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561308
- Sponsor's protocol ID
- PRO2024393
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected during the trial will be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer in Clinical Efficacy
- ClinicalTrials.gov ID
- NCT06561308
- Acronym / sponsor ID
- PRO2024393
- Conditions
- Endometrioid Endometrial Cancer
- Keywords
- Neoadjuvant chemotherapy, PD-1 inhibitor (Camrelizumab)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Tongji Hospital, Qilu Hospital of Shandong University, Anhui Provincial Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Henan Provincial People's Hospital, Hunan Cancer Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Medical University General Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer
Detailed description
Conduct domestic multicenter, prospective phase II single arm clinical trials to answer the following questions：
- Evaluate the impact of neoadjuvant chemotherapy combined with camrelizumab on the remission rate, surgical complications, and surgical resection rate of advanced stage III-IV endometrial cancer;
- Evaluate the effect of of neoadjuvant chemotherapy combined with camrelizumab on the survival of patients with advanced III-IV endometrial cancer;
- Exploring the changes in tumor local immune related factors and cells before and after neoadjuvant chemotherapy and camrelizumab use, as well as the responsiveness of different molecular subtypes of endometrial cancer to neoadjuvant therapy,.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Carboplatin AUC=5 q3w , paclitaxel 175 mg/m2 q3w and Camrelizumab iv.200mg q3w
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma | Experimental | Drug: Camrelizumab, Drug: Carboplatin, Drug: Paclitaxel, Procedure: SurgeryPatients with advanced endometrial cancer were enrolled for 2 or 3 cycles of neoadjuvant chemotherapy in combination with camrelizumab, with imaging to assess efficacy; intermittent subtractive surgery (transabdominal hysterectomy + bilateral adnexectomies + pelvic lymph node dissection + pelvic and abdominal tumors resections +/- para-abdominal aortic lymph node dissection) was performed in patients with complete remissions (CR)/partial remissions (PR), and continued with 3 or 4 cycles of neoadjuvant chemotherapy in combination with camrelizumab, ensuring that all patients receive a total of 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation
- Pathologically confirmed endometrial cancer that looks like endometrial carcinoma
- Patient age ≥18 years and ≤75 years old
- ECOG status score of 0-1
- tolerate surgery and systemic therapy
Key exclusion criteria (21 listed)
- 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;
- 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;
- Known hypersensitivity to any component and/or any excipient of the trial regimen;
- 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;
- Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CamrelizumabCamrelizumab is administered at 200mg, q3w，intravenous infusion | Drug | Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma |
| CarboplatinAUC=5，q3w，intravenous infusion | Drug | Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma |
| Paclitaxel175 mg/m2，q3w，intravenous infusion, administered over 30min. | Drug | Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma |
| SurgeryTransabdominal hysterectomy + bilateral adnexectomy + pelvic lymph node dissection + pelvic-abdominal tumor resection +/- para-abdominal aortic lymph node dissection | Procedure or surgery | Neoadjuvant chemotherapy combined with PD-1 inhibitor in FIGO III/IV Endometrial carcinoma |
Primary outcome
Pathologic complete response
Time frame: At the end of the patient's treatment, up to 1 years.
Proportion of patients with no tumor cells on postoperative pathology and negative lymph node metastasis
5 secondary outcomes
Surgical complication rate
Time frame: During and after the surgery, up to 2 years.
Adverse Event
Time frame: during the treatment, up to 5 years.
Remission rate (%) as assessed by RECIST 1.1 criteria
Time frame: At the end of the patient's treatment, up to 1 years.
Event-free survival (EFS)
Time frame: Until the end of the 3-year follow-up period, up to 5 years.
Overall survival (OS)
Time frame: Until the end of the 3-year follow-up period, up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected during the trial will be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Wang, PHD principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Carboplatin and Paclitaxel in people with Endometrioid Endometrial Cancer, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Li, PHD (0086-0571-87061501, li_yang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: At the end of the patient's treatment, up to 1 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.