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Cervical CancerPhase 2NCT06288360

Neoadjuvant Immunochemotherapy in PD-L1-negative LACC

A Phase 2 study testing Camrelizumab, Paclitaxel-albumin and Cisplatin 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

This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Camrelizumab, Paclitaxel-albumin and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
12 sitesChina
Study dates
12 Sep 2024to 12 Dec 2030
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • FIGO 2018 stage IB3, IIA2, or IIB/IIIC1r (tumor size>4cm) cervical cancer and without any treatment (After undergoing gynecological examinations by two associate chief physicians or above, the staging of the patients was determined);
  • Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. In principle, the size of the lesion as shown by the magnetic resonance imaging examination is used as the criterion.
  • Histologically confirmed squamous carcinoma, adenocarcinoma (common type) or adenosquamous carcinoma of the cervix;
  • Negative PD-L1 expression on preoperative pathological examination (Combined positive score < 1);
  • 18-70 years of age;
  • Eastern Cooperative Oncology Group score ≤ 1;
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  • WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥100×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value;
  • Well-compliance and willing to keep in touch;
  • Willing to participate in this study, sign the informed consent, and comply with the requirements and limitations outlined in the Informed Consent Form (ICF) and this form.

Who cannot join

  • Active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for the following: vitiligo, alopecia areata, Graves's 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 antibodies against immune co-stimulators (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), or any other therapy targeting a tumor's immune mechanism of action;
  • Known hypersensitivity to any component and/or any excipient of the trial prescribed medication;
  • Immunosuppressive drugs or systemic corticosteroids for immunosuppression (> 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, patients with hepatitis B who have received treatment and are in stable condition (HBV < 1000 IU/mL), and patients with cured hepatitis C are 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;
  • Have received a prior allogeneic bone marrow transplant or solid organ transplant;
  • History of primary malignant tumor within the last 5 years;
  • 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 the implantable infusion device is permitted;
  • With a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;
  • Uncontrolled other co-morbidities, symptoms, or medical history, including (i) persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina, pulmonary embolism, acute/continuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, or other arterial or venous thrombosis, embolism, or cerebral ischemic event of clinical significance/requiring pharmacologic intervention; and persons who have had, within 6 months, a symptoms of congestive heart failure (New York Heart Association (NYHA) class III and above); (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 abscesses, and gastrointestinal obstruction; and (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring Repeated drainage of ascites; ⑤ Abnormal liver or kidney development or history of surgery;
  • Pregnant or breastfeeding female patients; 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 judgment 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. Patients who, in the judgment of the Investigator, are unlikely to comply with the study steps, restrictions, and requirements are not permitted to participate in this 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

Jie Yang contact

086-027-8362

yangjie@tjh.tjmu.edu.cn

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 Wang, 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 Wang, 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

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

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

    Yingmei Wang, PhD

    Recruiting

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

    Wuhan, Hubei, 430030

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

    Kezhen Li

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Chemotherapy Plus Camrelizumab in PD-L1-negative Locally Advanced Cervical Cancer: a Multicentre, Single-arm, Phase 2 Trial

This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer.

Read the detailed description

This multicenter, prospective, single-arm clinical trial is designed to enroll patients with PD-L1-negative, locally advanced cervical cancer. Patients will receive an initial course of priming neoadjuvant chemotherapy, followed by two courses of neoadjuvant immunochemotherapy. The study aims to evaluate the effects of combining neoadjuvant chemotherapy with a PD-1 inhibitor on tumor remission rates, surgical complications, positive margin rates, and patient survival. Additionally, the trial will investigate changes in local immune-related factors and tumor cells during treatment, as well as identify biomarkers that may influence the efficacy of neoadjuvant immunochemotherapy.

Being tested
Camrelizumab, Paclitaxel-albumin, Cisplatin, radical surgery
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

    Also called SHR-1210

    200 mg, intravenously, 20-60 min. 2 times, every 21 days

  • Paclitaxel-albuminDrug

    Also called Injectable paclitaxel (albumin bound)

    260 mg/m² over 30 min, 3 times, every 21 days

  • CisplatinDrug

    Also called Cisplatin injection

    4 h, 75-80 mg/m², 3 times, every 21 days

  • radical surgeryProcedure or surgery

    Radical hysterectomy + pelvic lymphadenectomy 士 para-aortic lymphadenectomy

Study groups in NCT06288360
Study groupRoleWhat they receive
Neoadjuvant chemotherapy plus camrelizumab (NACI)ExperimentalPatients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. Patients with stable disease or progressive disease received concurrent chemoradiotherapy, and patients with a complete response or partial response proceeded to radical surgery.
Receives: Drug: Camrelizumab; Drug: Paclitaxel-albumin; Drug: Cisplatin; Procedure: radical surgery

What is being measured

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

  1. Pathologic complete response

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

    Measured: undergoing surgery; up to 2 years.

Secondary outcomes (7)

  1. Surgical Complications

    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: during and after surgery; an average of 3 years.

  2. Objective response rate

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

    Measured: measured 3 weeks after the last dose of neoadjuvant treatment and before surgery; up to 2 years.

  3. Positive surgical margin rate

    A positive surgical margin means that cancer cells are present at the edge of the resection specimen.

    Measured: undergoing surgery; 2 years

  4. event-free survival

    Event-free survival (EFS) refers to the possibility of experiencing a defined set of events (including progression such as metastasis, death, etc.) following NACI treatment.

    Measured: 7 years

  5. overall survival

    the time from enrollment to death

    Measured: 7 years

  6. adverse event

    an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.

    Measured: 7 years

  7. Patient Reported Outcomes

    including global quality of life and measures of sexual health

    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 start12 Sep 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion12 Dec 2030 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06288360
Sponsor's protocol ID
NACI-CERV-002
Other IDs
MA-CervC-II-007, [2024](S019)
Status last verified
Oct 2024
First submitted
18 Feb 2024
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
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 study testing Camrelizumab, Paclitaxel-albumin and Cisplatin 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 9 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 20 Mar 2025. 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 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 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?

Pathologic complete response (time frame: undergoing surgery; up to 2 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 NCT06288360.

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 20 Mar 2025.

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