Cervical CancersPhase 2/3NCT06866951

A Clinical Study Comparing Chemotherapy Combined With PD-1 Inhibitor Versus Concurrent Chemoradiotherapy in Cervical Cancer Patients With Positive Lymph Nodes After Surgery: A Multicenter Randomized Controlled Clinical Trial

A Phase 2/3 study testing Chemo-immunotherapy and CCRT in people with Cervical Cancers, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study aims to conduct a prospective, multicenter, randomized controlled trial targeting patients with cervical cancer who have been pathologically confirmed to have lymph node metastasis after surgery. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Cervical Cancers
What is being tested?: Chemo-immunotherapy and CCRT
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: 1 Mar 2025to 31 Dec 2030
Phase: Phase 2/3
Are there results?: None posted in the registry

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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with cervical squamous cell carcinoma, adenocarcinoma (usual type), or adenosquamous carcinoma who have been pathologically confirmed to have positive retroperitoneal lymph nodes after radical surgery for cervical cancer, i.e., patients with stage IIIC1p and IIIC2p cervical cancer (FIGO 2018);
Positive expression of PD-L1 in pathological examination, i.e., Combined Positive Score (CPS) ≥1;
Patients aged ≥18 years and ≤70 years;
ECOG performance status score ≤1;
Laboratory tests: White blood cell count (WBC) ≥3.5×10^9/L, neutrophil count (NEU) ≥1.5×10^9/L, platelet count (PLT) ≥100×10^9/L, serum total bilirubin ≤1.5 times the upper limit of normal, serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤1.5 times the upper limit of normal, serum blood urea nitrogen (BUN) ≤1.5 times the upper limit of regular or creatinine clearance rate ≥50 mL/min (creatinine clearance rate can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration formula, or the Modification of Diet in Renal Disease formula);
Good compliance of the subjects, who can follow the protocol for efficacy follow-up and adverse events/reactions;
Subjects voluntarily sign the informed consent form, including adherence to the requirements and restrictions listed in the informed consent form and this protocol.

Who cannot join

Postoperative pathology indicates positive parametrial involvement or positive surgical margins;
Incomplete radical surgery;
Postoperative imaging confirms the presence of residual target lesions;
Any active autoimmune disease or a history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, and asthma requiring intervention with bronchodilators;
Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known allergy to any component of the study medication or other monoclonal antibodies;
History of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay method);

Show all 21Show fewer

Receipt of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 2 weeks before the study drug administration (dose >10 mg/day of prednisone or equivalent);
Diagnosis of another primary malignancy within 5 years before the first use of the investigational drug.
Use any other investigational drug/treatment from another clinical trial within 4 weeks before randomization or concurrent participation in another interventional clinical trial. Participation in observational, non-interventional clinical trials is permitted;
Pregnant or breastfeeding female patients;
Uncontrolled concomitant diseases, including but not limited to:
Cardiovascular diseases: New York Heart Association (NYHA) functional class II or higher, severe/unstable angina, myocardial infarction within ≤6 months before study drug administration, or significant arrhythmias requiring medication or intervention;
Uncontrolled hypertension;
Cerebrovascular events or central nervous system disorders within ≤6 months before study drug administration, or patients with abnormal mental status;
Hematologic disorders: Coagulopathy (INR > 2.0, PT > 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy;
Hepatic or renal developmental abnormalities or history of surgery;
Any active infection requiring systemic antimicrobial therapy within 14 days before the first dose of the study drug;
Receipt of any live or attenuated vaccines within 4 weeks before the first dose of the study drug. Administration of seasonal inactivated influenza vaccine is permitted;
Patients who have previously undergone allogeneic bone marrow transplant or solid organ transplantation;
History of drug and/or alcohol abuse;
Patients deemed by the investigator unlikely to comply with study procedures, restrictions, and requirements are not eligible for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Womens' Hosptial, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: CIT Trial for Cervical Cancer Patients

Patients who have undergone cervical cancer surgery and have been pathologically confirmed to have positive retroperitoneal lymph nodes will be selected according to the inclusion and exclusion criteria. Their clinical and pathological data will be collected. These patients will be randomly assigned in a 1:1 ratio to two groups: the chemotherapy-immunotherapy (chemo-immunotherapy) group and the concurrent chemoradiotherapy group.

The study will compare the two treatment strategies by evaluating tumors' 3-year recurrence rate, distant metastasis rate, and overall survival prognosis in patients. The primary endpoints are the 3-year recurrence rate and distant metastasis rate. Secondary endpoints include the 3-year local recurrence rate, progression-free survival (PFS), and overall survival (OS). Additionally, the study will assess differences in complications, toxic side effects of chemotherapy and radiotherapy, and quality of life between the two groups to determine the value of chemo-immunotherapy in treating this patient population.

In addition, biological tissue samples from 50 patients in the chemo-immunotherapy cohort will be collected for multi-omics analysis and detection of immune-related biomarkers. Using bioinformatics methods, the study will analyze the differences in cellular immune subtypes and immune-related biomarkers between patients who benefit from the treatment and those who do not. This analysis aims to clarify the therapeutic efficacy of chemo-immunotherapy in patients with postoperative lymph node metastasis after cervical cancer surgery and to identify biomarkers and immune markers associated with treatment benefits.

Conditions: Cervical Cancers
Being tested: Chemo-immunotherapy, CCRT
Medical subject headings: Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chemo-immunotherapyDrug
Post-radical surgery for cervical cancer, the first cycle of PD-1 inhibitor combined with chemotherapy will begin 2 to 3 weeks after surgery. Each treatment cycle lasts 21 days, with a total of 6 cycles. A complete imaging efficacy evaluation will be conducted after every 3 treatment cycles. For patients with lymph node metastasis ≥3 or para-aortic lymph node metastasis, 6 cycles of chemotherapy combined with immunotherapy will be administered. Other patients will receive 3 cycles of chemotherapy combined with immunotherapy.
Treatment regimen:
Day 1:
Paclitaxel (albumin-bound) for injection: 260 mg/m², administered intravenously over 30 minutes.
Day 1 to Day 2:
Cisplatin 75-80 mg/m², administered intravenously at a 1 mg/min rate.
Day 3:
PD-1 inhibitor (Camrelizumab for injection, Aikening): 200 mg per dose, infused over 30 to 60 minutes.
CCRTRadiation
The overall chemoradiotherapy (including EBRT and brachytherapy) should typically be completed within 6 weeks (with a maximum extension to 10 weeks in case of anticipated delays). External beam radiotherapy (EBRT) should be at least three-dimensional conformal radiotherapy, with image-guided (CT or MR) intensity-modulated conformal radiotherapy techniques recommended, at a 45-50 Gy dose.
Concurrent Chemotherapy:
Cisplatin (40 mg/m²) is preferred on a weekly schedule (administered before the planned EBRT on the same day, once a week [±1-day window], for a total of 5-6 infusions). Carboplatin can be used as an alternative if cisplatin toxicity is not tolerated.

Study groups in NCT06866951
Study group	Role	What they receive
Chemo-immunotherapy group	Experimental	Post-radical surgery for cervical cancer, the first cycle of PD-1 inhibitor combined with chemotherapy will begin 2 to 3 weeks after surgery. Each treatment cycle lasts 21 days, with a total of 6 cycles. A complete imaging efficacy evaluation will be conducted after every 3 treatment cycles. For patients with lymph node metastasis ≥3 or para-aortic lymph node metastasis, 6 cycles of chemotherapy combined with immunotherapy will be administered. Other patients will receive 3 cycles of chemotherapy combined with immunotherapy. Treatment regimen: Day 1: Paclitaxel (albumin-bound) for injection: 260 mg/m², administered intravenously over 30 minutes. Day 1 to Day 2: Cisplatin 75-80 mg/m², administered intravenously at a 1 mg/min rate. Day 3: PD-1 inhibitor (Camrelizumab for injection, Aikening): 200 mg per dose, infused over 30 to 60 minutes. Receives: Drug: Chemo-immunotherapy
CCRT group	Active comparator	Standard treatment includes cisplatin, external beam radiotherapy (EBRT), and brachytherapy. The overall chemoradiotherapy (including EBRT and brachytherapy) should typically be completed within 6 weeks (with a maximum extension to 10 weeks in case of anticipated delays). External beam radiotherapy (EBRT) should be at least three-dimensional conformal radiotherapy, with image-guided (CT or MR) intensity-modulated conformal radiotherapy techniques recommended, at a 45-50 Gy dose. Concurrent Chemotherapy: Cisplatin (40 mg/m²) is preferred on a weekly schedule (administered before the planned EBRT on the same day, once a week [±1-day window], for a total of 5-6 infusions). Carboplatin can be used as an alternative if cisplatin toxicity is not tolerated. Receives: Radiation: CCRT

What is being measured

The primary outcome is the main question the study is designed to answer.

3-year recurrence rate
Measured: From enrollment to the end of treatment at 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202531 Dec 2030

First posted10 Mar 2025
Study start1 Mar 2025
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2030 (estimated)

Why it stopped: no participants enrolled

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancersStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06866951
Sponsor's protocol ID: PRO2024-777
Status last verified: Dec 2025
First submitted: 4 Mar 2025
Last updated: 16 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2
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RecruitingPhase 4
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All Cervical Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CIT Trial for Cervical Cancer Patients
ClinicalTrials.gov ID: NCT06866951
Acronym / sponsor ID: PRO2024-777
Conditions: Cervical Cancers
Phase: Phase 2/3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: no participants enrolled
Enrolment: 0 participants (actual)
Lead sponsor: Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
Study start: 1 Mar 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 10 Mar 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chemo-immunotherapy group	Experimental	Drug: Chemo-immunotherapyPost-radical surgery for cervical cancer, the first cycle of PD-1 inhibitor combined with chemotherapy will begin 2 to 3 weeks after surgery. Each treatment cycle lasts 21 days, with a total of 6 cycles. A complete imaging efficacy evaluation will be conducted after every 3 treatment cycles. For patients with lymph node metastasis ≥3 or para-aortic lymph node metastasis, 6 cycles of chemotherapy combined with immunotherapy will be administered. Other patients will receive 3 cycles of chemotherapy combined with immunotherapy. Treatment regimen: Day 1: Paclitaxel (albumin-bound) for injection: 260 mg/m², administered intravenously over 30 minutes. Day 1 to Day 2: Cisplatin 75-80 mg/m², administered intravenously at a 1 mg/min rate. Day 3: PD-1 inhibitor (Camrelizumab for injection, Aikening): 200 mg per dose, infused over 30 to 60 minutes.
CCRT group	Active comparator	Radiation: CCRTStandard treatment includes cisplatin, external beam radiotherapy (EBRT), and brachytherapy. The overall chemoradiotherapy (including EBRT and brachytherapy) should typically be completed within 6 weeks (with a maximum extension to 10 weeks in case of anticipated delays). External beam radiotherapy (EBRT) should be at least three-dimensional conformal radiotherapy, with image-guided (CT or MR) intensity-modulated conformal radiotherapy techniques recommended, at a 45-50 Gy dose. Concurrent Chemotherapy: Cisplatin (40 mg/m²) is preferred on a weekly schedule (administered before the planned EBRT on the same day, once a week [±1-day window], for a total of 5-6 infusions). Carboplatin can be used as an alternative if cisplatin toxicity is not tolerated.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with cervical squamous cell carcinoma, adenocarcinoma (usual type), or adenosquamous carcinoma who have been pathologically confirmed to have positive retroperitoneal lymph nodes after radical surgery for cervical cancer, i.e., patients with stage IIIC1p and IIIC2p cervical cancer (FIGO 2018);
Positive expression of PD-L1 in pathological examination, i.e., Combined Positive Score (CPS) ≥1;
Patients aged ≥18 years and ≤70 years;
ECOG performance status score ≤1;
Laboratory tests: White blood cell count (WBC) ≥3.5×10^9/L, neutrophil count (NEU) ≥1.5×10^9/L, platelet count (PLT) ≥100×10^9/L, serum total bilirubin ≤1.5 times the upper limit of normal, serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤1.5 times the upper limit of normal, serum blood urea nitrogen (BUN) ≤1.5 times the upper limit of regular or creatinine clearance rate ≥50 mL/min (creatinine clearance rate can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration formula, or the Modification of Diet in Renal Disease formula);

Key exclusion criteria (21 listed)

Postoperative pathology indicates positive parametrial involvement or positive surgical margins;
Incomplete radical surgery;
Postoperative imaging confirms the presence of residual target lesions;
Any active autoimmune disease or a history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, and asthma requiring intervention with bronchodilators;
Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known allergy to any component of the study medication or other monoclonal antibodies;

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
Chemo-immunotherapyPost-radical surgery for cervical cancer, the first cycle of PD-1 inhibitor combined with chemotherapy will begin 2 to 3 weeks after surgery. Each treatment cycle lasts 21 days, with a total of 6 cycles. A complete imaging efficacy evaluation will be conducted after every 3 treatment cycles. For patients with lymph node metastasis ≥3 or para-aortic lymph node metastasis, 6 cycles of chemotherapy combined with immunotherapy will be administered. Other patients will receive 3 cycles of chemotherapy combined with immunotherapy. Treatment regimen: Day 1: Paclitaxel (albumin-bound) for injection: 260 mg/m², administered intravenously over 30 minutes. Day 1 to Day 2: Cisplatin 75-80 mg/m², administered intravenously at a 1 mg/min rate. Day 3: PD-1 inhibitor (Camrelizumab for injection, Aikening): 200 mg per dose, infused over 30 to 60 minutes.	Drug	Chemo-immunotherapy group
CCRTThe overall chemoradiotherapy (including EBRT and brachytherapy) should typically be completed within 6 weeks (with a maximum extension to 10 weeks in case of anticipated delays). External beam radiotherapy (EBRT) should be at least three-dimensional conformal radiotherapy, with image-guided (CT or MR) intensity-modulated conformal radiotherapy techniques recommended, at a 45-50 Gy dose. Concurrent Chemotherapy: Cisplatin (40 mg/m²) is preferred on a weekly schedule (administered before the planned EBRT on the same day, once a week [±1-day window], for a total of 5-6 infusions). Carboplatin can be used as an alternative if cisplatin toxicity is not tolerated.	Radiation	CCRT group

Primary outcome

3-year recurrence rate
Time frame: From enrollment to the end of treatment at 3 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Cervical Cancers

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Chemo-immunotherapy and CCRT in people with Cervical Cancers, 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 7 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: withdrawn, as of the sponsor's last update on 16 Dec 2025. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year recurrence rate (time frame: From enrollment to the end of treatment at 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866951.

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 16 Dec 2025.