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Cervical CancerPhase 2NCT04974827

A Study of Camrelizumab Combined With Concurrent Chemoradiation in Patients With Cervical Cancer

A Phase 2 study testing Camrelizumab and Cisplatin or Carboplatin in people with Cervical Cancer, run by Hunan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this single-arm study, patient with cervical cancer who had recurrence of the pelvic wall after surgery ± Abdominal aortic lymph node metastasis will be included to evaluate the efficacy and safety of camrelizumab combined with concurrent chemoradiation and subsequent maintenance therapy Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Camrelizumab and Cisplatin or Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
20 May 2021to 20 May 2023
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old
  • Understand the research procedures and content, and voluntarily sign informed consent
  • Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma confirmed by histology or cytology
  • Patients diagnosed as recurrent cervical cancer on the pelvic wall by histology or cytology. If histology or cytology is not available, provide clinical diagnosis in combination with medical history, laboratory examinations and imaging examinations (such as CT, MRI, PET/CT)
  • According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion on the pelvic wall by CT or MRI (the longest diameter ≥10mm lesion, or the short diameter ≥15mm lymph node)
  • CT or MRI examination or PET-CT examination showed no distant metastasis
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  • Expected survival period ≥ 3 months
  • ECOG score: 0-1
  • Participants need to provide sufficient formalin-fixed paraffin-embedded (FFPE) specimens or sections prepared from tumor archive tissues or fresh tissues that meet the testing standards, and are willing to perform tumor tissue biopsy when needed for PD-L1 Detection. The archived tissue must be a representative tumor specimen within three years, or an unstained serial section (not less than 4 pieces) of newly cut FFPE tumor tissue within six months, and relevant pathological reports of the above specimens must be provided. The methods of obtaining fresh tissue specimens can be surgical resection and biopsy. The methods of biopsy include but are not limited to core needle biopsy, endoscopic resection or clamp biopsy (enough tumor cells must be guaranteed> 100); Fine needle aspiration and liquid-based cytology (TCT) samples are not accepted (it means that there isn't a complete tissue structure and Participants only provide cell suspension and/or cell smears); Decalcified bone metastasis tumor tissue specimens are not accepted. For patients who are PD-L1 negative in the initial archived tumor tissue samples, after obtaining the patient's consent, a biopsy can be performed during screening to provide wax blocks or sections prepared from fresh tissues to retest PD-L1 status
  • The investigator assesses suitability for concurrent chemoradiation
  • The values of laboratory tests performed during the screening period must meet the following criteria Hemoglobin (HGB) ≥90g/L Absolute neutrophil count (ANC) ≥1.5×109/L Platelet (PLT) ≥100×109/L Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
  • Thyroid function index: free thyroxine (FT3/FT4) in the normal range
  • Subjects can be followed up on schedule, can communicate well with the investigator and can complete the study in accordance with the regulations of this study

Who cannot join

  • Histological examination results are small cell (neuroendocrine) cervical cancer and mucinous adenocarcinoma
  • CT, MRI or PET-CT examination shows diffuse pelvic metastasis
  • CT, MRI or PET-CT examination shows distant metastasis (excluding retroperitoneal lymph node metastasis)
  • Simple vaginal recurrence
  • Active central nervous system (CNS) metastases, including symptomatic brain metastases,meningeal metastases or spinal cord compression, etc.Asymptomatic brain metastases can be included in the group (no progression for at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection, no need for treatment with glucocorticoids, anticonvulsants or mannitol)
  • Systemic chemotherapy, targeted therapy, anti-tumor biological therapy (such as tumor vaccine, cytokine or growth factor, etc.) have been performed before the study drug
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  • The effect of major surgery or severe trauma before study medication has been eliminated within 14 days(Those who have undergone local anesthesia or percutaneous needle biopsy within 7 days and have recovered can be included in the group)
  • Participants received systemic corticosteroids (prednisone>10mg/day or equivalent dose) or other immunosuppressive drugs within 14 days before the study medication
  • A history of active and known autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except for type I diabetes, hypothyroidism that can be controlled only by hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo), and controlled celiac disease
  • Complications that need to be treated with immunosuppressive drugs, or Complications that need to be treated systemically with an immunosuppressive dose (prednisone> 10 mg/day or equivalent dose of similar drugs). In the absence of active autoimmune diseases, inhaled or topical steroids and doses> 10mg/day of prednisone or equivalent doses of similar drugs are allowed
  • Uncontrolled hypertension (systolic blood pressure> 140 mmHg and/or diastolic blood pressure> 90 mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass or stent surgery within 6 months before administration. A history of chronic heart failure that meets NYHA standards 3-4; clinically significant valvular disease; Severe arrhythmia requiring treatment, including QTc interval ≥470ms (calculated by Fridericia formula); left ventricular ejection fraction (LVEF) <50%;Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration.
  • Combined with other serious medical diseases, including but not limited to uncontrolled diabetes, active peptic ulcer, active bleeding, etc.
  • Patients with active infection who need systemic treatment
  • Patients with previous or current active tuberculosis infection
  • The patient has a history of interstitial lung disease
  • Symptomatic and uncontrollable serous effusion such as peritoneal effusion, pleural effusion or pericardial effusion
  • Human immunodeficiency virus antibody (HIV-Ab) positive; patients with active syphilis infection; hepatitis C antibody (HCV-Ab) positive, and hepatitis C virus RNA quantification> the upper limit of normal value of detection unit; hepatitis B virus surface antigen (HBsAg) is positive, and hepatitis B Virus detection value> upper limit of normal value of detection unit
  • Adverse reactions caused by previous treatment have not recovered to grade 1 or below (CTCAE5.0) (except for hair loss and grade 2 neurotoxicity caused by chemotherapy drugs)
  • Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway)
  • Radiotherapy has been performed on the area to be irradiated in the past
  • Have used live vaccines or attenuated vaccines within 28 days before study medication
  • Participants have used other investigational drug treatments or investigational devices within 30 days before the study medication
  • People with a history of drug abuse or drug abuse
  • Have a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance
  • Women who are breastfeeding and do not agree to stop breastfeeding
  • Patients are known to be allergic to recombinant humanized PD-1 monoclonal antibody or any of its excipients; patients are known to have a history of allergic diseases or have severe allergies
  • The investigator believes that the patient is not suitable for participating in this clinical research for various other reasons

Trial locations and contacts

1 site in 1 country.

Chaoxia Liu contact

188 9006 9917

liuchaoxia@hnca.org.cn

China1 site, 1 recruiting

  • Hunan cancer Hospital

    Changsha, Hunan, 410013

    Chaoxia Liu, 188 9006 9917, liuchaoxia@hnca.org.cn

    Chaoxia c Liu

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multi-center Phase II Clinical Study of Camrelizumab Combined With Concurrent Chemoradiation in Patients With Cervical Cancer Who Had Recurrence of the Pelvic Wall After Surgery ± Abdominal Aortic Lymph Node Metastasis

In this single-arm study, patient with cervical cancer who had recurrence of the pelvic wall after surgery ± Abdominal aortic lymph node metastasis will be included to evaluate the efficacy and safety of camrelizumab combined with concurrent chemoradiation and subsequent maintenance therapy

Read the detailed description

The patient received neoadjuvant therapy once every three weeks for a total of seventeen cycles. From the first day of treatment, the patient will undergo concurrent chemoradiation for 5 weeks.The chemotherapy drug is cisplatin or carboplatin every week for 5 weeks. After the end of concurrent chemoradiation, the patient will continue to use camrelizumab as maintenance therapy until one year.

Conditions
Cervical Cancer
Being tested
Camrelizumab, Cisplatin or Carboplatin
Keywords
immunotherapy, PD-1 checkpoint inhibitor, concurrent chemoradiation
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

    200mg/3weeks

  • Cisplatin or CarboplatinDrug

    Cisplatin (40mg/m²), every week Carboplatin(AUC 2)

Study groups in NCT04974827
Study groupRoleWhat they receive
Camrelizumab , Cisplatin or CarboplatinExperimentalParticipants will be given intravenous administration of Camrelizumab (200mg) ,Cisplatin(40mg/m²) or Carboplatin(AUC 2) and Radiotherapy. After completing 5 cycles of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until one year.
Receives: Drug: Camrelizumab; Drug: Cisplatin or Carboplatin

What is being measured

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

  1. Complete remission rate (CR)

    Evaluate the efficacy of camrelizumab combined with Concurrent chemoradiation in patients with cervical cancer who had recurrence of the pelvic wall after surgery ± Abdominal aortic lymph node metastasis. Use RECIST 1.1 evaluation criteria for evaluation and the unit is '%'.

    Measured: immediately after the concurrent chemoradiation

Secondary outcomes (5)

  1. objective response rate (ORR) duration of response in CR patients (DOR) disease control rate (DCR) progression-free survival (PFS) overall survival (OS) other efficacy indicators

    The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit is the sum of the proportions of complete remission and partial remission. Use RECIST 1.1 evaluation criteria for evaluation and the unit is '%'.

    Measured: immediately after the concurrent chemoradiation

  2. Disease Control Rate (DCR)

    The proportion of patients whose tumors have shrunk or stabilized for a certain period of time, including complete remission, partial remission and stable cases. Use RECIST 1.1 evaluation criteria for evaluation and the unit is '%'.

    Measured: 1 year

  3. overall survival (OS)

    Time from receiving treatment to death (for any reason). Evaluation based on follow-up and the unit is 'years'.

    Measured: 1 year

  4. duration of response (DOR)

    It refers to the time from the first evaluation of the tumor as CR or PR to the first evaluation as PD (Progressive Disease) or death from any cause. Use RECIST 1.1 evaluation criteria for evaluation and the unit is 'years'.

    Measured: 1 year

  5. Progression-free survival (PFS)

    The time span from the beginning of treatment of the tumor to the appearance of secondary growth of the tumor. It means that the tumor has basically not progressed at this stage. Use RECIST 1.1 evaluation criteria for evaluation and the unit is 'years'.

    Measured: 1 year

Timeline

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

  1. First posted23 Jul 2021
  2. Study start20 May 2021
  3. Primary completion20 May 2023 (estimated)
  4. Study completion20 May 2023 (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
Model description
Patients fulfilling Eligibility Criteria will be included in this study.Participants will be given intravenous administration of Camrelizumab (200mg) ,Cisplatin(40mg/m²) or Carboplatin(AUC 2) and Radiotherapy. After completing 5 cycles of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until one year.
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974827
Sponsor's protocol ID
HNCHIIT003
Status last verified
Jul 2021
First submitted
5 Jul 2021
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab and Cisplatin or Carboplatin in people with Cervical Cancer, run by Hunan Cancer Hospital 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 13 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. 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?

Results are not available in the source record.

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

Contact Chaoxia Liu (188 9006 9917, liuchaoxia@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate (CR) (time frame: immediately after the concurrent chemoradiation). 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 NCT04974827.

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 10 Aug 2021.

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