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

NCT04974827 | Unknown Phase 2

• 1 other identifier: HNCHIIT003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cervical Cancer

Keywords

immunotherapy; PD-1 checkpoint inhibitor; concurrent chemoradiation

Outcome Measures

Primary Outcomes (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 '%'.

  immediately after the concurrent chemoradiation

Secondary Outcomes (5)

• 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

  immediately after the concurrent chemoradiation

• Disease Control Rate (DCR)

  1 year

• overall survival (OS)

  1 year

• duration of response (DOR)

  1 year

• Progression-free survival (PFS)

  1 year

Study Arms (1)

Camrelizumab , Cisplatin or Carboplatin

EXPERIMENTAL

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.

Drug: Camrelizumab; Drug: Cisplatin or Carboplatin

Interventions

Camrelizumab DRUG

200mg/3weeks

Camrelizumab , Cisplatin or Carboplatin

Cisplatin or Carboplatin DRUG

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

Camrelizumab , Cisplatin or Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hunan cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

camrelizumab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Chaoxia c Liu

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoxia Liu

CONTACT

188 9006 9917; liuchaoxia@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 23, 2021
• Study Start: May 20, 2021
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author of published work

Locations

CN (1)