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Cervical CancerPhase 2/3NCT06288373

Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC

A Phase 2/3 study testing Camrelizumab, Cisplatin and Nab paclitaxel in people with Cervical Cancer and Locally Advanced Cervical Cancer, run by Tongji Hospital at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors >4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Camrelizumab, Cisplatin and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
12 sitesChina
Study dates
22 Apr 2024to 1 Mar 2031
Phase
Phase 2/3
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced (2018 FIGO staged IB3, IIA2 and IIB（tumor size> 4cm) ) cervical cancer，staging determined by two physicians of associate seniority or higher after gynecologic examination and imaging evaluation);
  • At least one measurable lesion at baseline according to RECIST 1.1 criteria, with lesion size based primarily on magnetic resonance imaging;
  • Pathologically confirmed diagnosis of cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma (common type), and adenosquamous carcinoma;
  • Positive PD-L1 expression, Combined Positive Score (CPS) ≥1;
  • Patient age ≥18 years and ≤70 years;
  • ECOG score ≤1;
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  • Laboratory tests: WBC (white blood cell count) ≥ 3.5×109/L, NEU (neutrophil count) ≥ 1.5×109/L, PLT (platelet count) ≥ 100×109/L, total bilirubin ≤ 1.5 times the upper limit of normal, ALT (alanine aminotransferase) and AST (aspartate aminotransferase) ≤ 1.5 times the upper limit of normal, serum creatinine (BUN) ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration equation, or the Modification of Diet in Renal Disease equation);
  • Be willing to follow up and good compliance;
  • Be willing to sign the informed consent, including compliance with the requirements and restrictions listed in the informed consent and program；
  • Agree to use effective contraception measures during the trial period and for 5 months after the last dose of pembrolizumab or 6 months after chemotherapy (whichever is longer).

Who cannot join

  • Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
  • Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;
  • Has a history of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive, and HCV-RNA above the lower limit of detection of the assay);
  • Receipt of immunosuppressive medications or systemic corticosteroid therapy for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to study dosing;
  • Diagnosed with another primary malignancy within 5 years prior to the first use of the investigational drug;
  • Received other investigational drugs/treatments or participated in another clinical trial within 4 weeks prior to randomization. Participation in observational and non-interventional clinical trials is allowed;
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  • Pregnant or breastfeeding female patients;
  • Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe/unstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or individuals with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR >2. 0, PT>16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and development of an active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;
  • Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;
  • Patients with a prior allogeneic bone marrow or solid organ transplant;
  • Drug and/or alcohol abuse;
  • Patients who, in the opinion of the investigator, are unlikely to comply with the procedures, restrictions, and requirements of the study may not be enrolled in the study.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kezhen Li contact

086-027-8362

tjkeke@126.com

Jing Chen contact

086-027-8362

chenjing3223@126.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Beiing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Zhiqi Wang, PhD, wangzqnet@sina.com

    Zhiqi Zhiqi, PhD

    Recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

    Yu Zhang, PhD, xyzhangyu@csu.edu.cn

    Yu Zhang, PhD

    Recruiting

  • Second People's Hospital of Sichuan (Sichuan Cancer Hospital)

    Chengdu, Sichuan, 610041

    Dengfeng Wang, PhD

    Dengfeng Wang, PhD

    Recruiting

  • The First Affiliated Hospital (Southwest Hospital), Army Medical University (Third Military Medical University)

    Chongqing, Chongqing Municipality, 400038

    Yanzhou Wang, PhD, w.y.z@foxmail.com

    Yanzhou Yanzhou, PhD

    Recruiting

  • Women's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310022

    Yuanming Shen, PhD, 5312010@zju.edu.cn

    Yuanming Shen, PhD

    Recruiting

  • Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences

    Hangzhou, Zhejiang, 310022

    Yingli Zhang, PhD, zhangyl@zjcc.org.cn

    Yingli Zhang, PhD

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

    Bairong Xia, PhD, xiabairong@ustc.edu.cn

    Bairong Bairong, PhD

    Recruiting

  • Gansu Provincial Maternity and Child-care Hospital

    Lanzhou, Gansu, 730050

    Yun Dang, PhD

    Yun Dang, PhD

    Recruiting

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Ying Long, PhD

    Ying Long, PhD

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Tingting Gong, PhD, gongtt@sj-hospital.org

    Tingting Gong, PhD

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Yingmei Wang, PhD, wangyingmei@tmu.edu.cn

    Yingmei Yingmei, PhD

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Kezhen Li, 086-027-8362, tjkeke@126.com

    Jing Chen, 086-027-8362, chenjing3223@126.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Chemoimmunotherapy Combined With Surgery Versus Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Multicenter Randomized Controlled Clinical Trial

It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors >4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group.

Read the detailed description

Cervical cancer is the most common gynecological malignancy in China, with locally advanced cervical cancer (LACC) accounting for approximately 37% of cases. Currently, the recommended standard of care for LACC according to international guidelines is concurrent chemoradiotherapy (CCRT). However, the impacts of radiation therapy on patients' quality of life are increasingly being recognized. Additionally, 23.3% to 34.4% of patients still face recurrence or metastasis after treatment, and the 5-year overall survival rate remains around 75%.

Neoadjuvant chemotherapy (NACT) is a chemotherapy regimen used prior to surgery for LACC. NACT followed by radical surgery has a similar overall survival compared to CCRT, but the disease-free survival is relatively lower with NACT. Moreover, 9.8% to 30.6% of patients show poor response to NACT, and over 30% of patients require postoperative adjuvant therapy. These issues significantly limit the application of NACT in LACC.

In recent years, immunotherapy has made significant progress in advanced or recurrent cervical cancer. A phase II clinical trial of combination of PD-1 inhibitors and neoadjuvant chemotherapy showed significant anti-tumor activity and safety. Therefore, based on the preliminary results, this project aims to conduct a multicenter, prospective, randomized controlled clinical trial to further confirm the value of neoadjuvant immunotherapy combined with surgery in LACC. It will be compared with the standard CCRT regimen to explore the differences in clinical efficacy and adverse events between the two groups, providing high-level evidence for the application of neoadjuvant immunotherapy in cervical cancer.

Being tested
Camrelizumab, Cisplatin, Nab paclitaxel, Radical surgery, external beam radiation therapy (EBRT) + brachytherapy
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.

  • CamrelizumabDrug

    Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery

  • CisplatinDrug

    Cisplatin：75-80mg/m2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg/min.

  • Nab paclitaxelDrug

    Nab paclitaxel: 260 mg/m2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.

  • Radical surgeryProcedure or surgery

    Radical surgery

  • external beam radiation therapy (EBRT) + brachytherapyRadiation

    Radiation therapy per standard of care

  • CisplatinDrug

    Chemotherapy administered concurrent with radiation therapy，cisplatin 40 mg/m2 IV once per week (QW) for 5 weeks

Study groups in NCT06288373
Study groupRoleWhat they receive
Camrelizumab combined neoadjuvant chemotherapy plus radical surgeryExperimentalPatients receive 1 cycle of cisplatin and nab paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of camrelizumab combined neoadjuvant chemotherapy. Based on the tumor size as indicated by MRI, patients who achieve complete response or partial response (CR/PR，RECIST v1.1) will undergo open radical hysterectomy and pelvic lymph node dissection. Patients who show stable disease or progression (SD/PD，v1.1) will proceed directly to concurrent chemoradiotherapy (CCRT).
Receives: Drug: Camrelizumab; Drug: Cisplatin; Drug: Nab paclitaxel; Procedure: Radical surgery
Concurrent Chemoradiotherapy (CCRT)Active comparatorPelvic EBRT + concurrent platinum-containing chemotherapy + brachytherapy
Receives: Radiation: external beam radiation therapy (EBRT) + brachytherapy; Drug: Cisplatin

What is being measured

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

  1. Progression-free survival, PFS

    PFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.

    Measured: 7 years

  2. Objective Response Rate, ORR

    The proportion of patients who had either complete response or partial response, assessed by independent central reviewers according to RECIST, version 1.1.

    Measured: 2 years

Secondary outcomes (7)

  1. Overall survival, OS

    OS is defined as the time from randomisation to death.

    Measured: 7 years

  2. Proportion of patients undergoing radical surgery

    Proportion of patients undergoing radical surgery for neoadjuvant chemoimmunotherapy plus surgery group

    Measured: 2 years

  3. Pathologic Complete Response

    Pathologic complete response (pCR) refers to the absence of invasive/in situ cancer in the cervical and/or lymph nodes.

    Measured: 2 years

  4. The surgical complication rate

    Intraoperative bleeding, vascular injuries, bladder injuries, rectal injuries, and ureteral injuries were measured by the need for suture repair; occlusive nerve injuries were measured by complete severance, and vascular injuries required documentation of the site of injury. Postoperative complications included: cervical stenosis, cervical insufficiency, 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: 2 years

  5. Safety and toleraty

    The incidence of adverse evetns, severe adverse events; surgery related safety.

    Measured: 7 years

  6. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.

    Measured: 7 years

  7. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score

    The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.

    Measured: 7 years

Timeline

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

  1. First posted1 Mar 2024
  2. Study start22 Apr 2024
  3. Primary completion1 Mar 2031 (estimated)
  4. Study completion1 Mar 2031 (estimated)

Resources

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
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288373
Sponsor's protocol ID
NACI-CERV-003
Other IDs
MA-CERVC-II/III-006, [2024](S018)
Status last verified
Oct 2024
First submitted
18 Feb 2024
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Camrelizumab, Cisplatin and Nab paclitaxel in people with Cervical Cancer and Locally Advanced Cervical Cancer, run by Tongji Hospital at 12 sites 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 12 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

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 Kezhen Li (086-027-8362, tjkeke@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival, PFS (time frame: 7 years). The study lists 2 primary outcomes in all. 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 NCT06288373.

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 30 Oct 2024.

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Clinical Trial NCT06288373 | AzTrials