A Study of Carilizumab Combined With Concurrent Chemoradiotherapy

NCT05151549 | Unknown Phase 2

• 1 other identifier: HNCHIIT103
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a one-arm phase II clinical study. In patients with stage III-IVA cervical cancer with pelvic lymph nodes \> 2cm, positive para-aortic lymph nodes, or lymph node metastases \> 2, patients with positive PD-L1 expression (CPS score ≥1) were treated with cararizumab combined with conventional concurrent chemoradiotherapy and immunomaintenance therapy for one year. To evaluate the efficacy and safety of carilizumab in combination with concurrent chemoradiotherapy and subsequent maintenance therapy.

Conditions

Cervical Cancer

Keywords

immunotherapy; PD-1 checkpoint inhibitor; concurrent chemoradiation

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate

  Proportional patient proportion to survival and non-progressive in the second year. Use RECIST 1.1 evaluation criteria for evaluation and the unit is 'years'.

  immediately after the concurrent chemoradiation

Secondary Outcomes (4)

• duration of response (DOR)

  1 year

• Progression-free survival (PFS)

  1 year

• overall survival (OS)

  1 year

• Disease Control Rate (DCR)

  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 17 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
• Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or stage III-IVA cervical carcinoma with adenocarcinoma;
• According to RECIST 1.1 criteria, subjects must have at least one of the following risk factors demonstrated by CT or MRI or PET-CT:1) Pelvic lymph nodes with short diameter ≥20mm and para-arterial lymph nodes with short diameter ≥10mm;2)The number of lymph nodes \> 2 (single lymph node with short diameter ≥10mm);
• CT, MRI, or PET-CT showed no distant metastasis;
• Expected survival period ≥ 3 months
• ECOG score: 0-1
• Subject will provide sufficient formalin fixed paraffin embedded (FFPE) specimens or sections of tumor archived tissue or fresh tissue that meet the test criteria and will be willing to undergo tumor biopsy for PD-L1 if required. The archived tissue must be a representative tumor specimen from less than 3 years old, or a series of unstained sections (not less than 4) of FFPE tumor tissue from less than 6 months old, and the relevant pathological report of the above specimens must be provided. Fresh tissue samples can be obtained by surgical resection or biopsy. The methods of biopsy include but are not limited to core needle biopsy, endoscopic resection or clamp biopsy (ensure sufficient tumor cells \> 100); Fine needle aspiration and liquid based cytology (TCT) samples are not accepted (i.e. samples that lack complete tissue structure and provide only cell suspension and/or cell smear); Demineralized specimens of bone metastases were not accepted. For patients with pD-L1 negative initial archived tumor tissue samples, biopsies may be performed at screening, subject to patient consent, to provide fresh tissue prepared wax blocks or slices for retesting for PD-L1 status.
• Investigator-assessed suitability for concurrent chemoradiotherapy;
• The values of laboratory tests performed for screening must meet the following criteria:
• Blood test 1) Hemoglobin (HGB) ≥90 g/L; 2) Absolute count of neutrophils (ANC) ≥1.5×109 /L; 3) Platelet (PLT) ≥100×109 /L; Biochemical examination 1) Total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome allowed ≤5×ULN); 2) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (if liver metastasis exists, ALT and AST≤5×ULN); 3) Serum creatinine (Cr) ≤1.5×ULN or endogenous creatinine clearance ≥50mL/min (Cockcroft Gault formula);
• Thyroid function indicators: thyroid stimulating hormone (TSH) and free thyroid hormone (FT3/FT4) were in the normal range; If TSH is not in the normal range, FT3 and FT4 can be grouped if they are in the normal range.
• The subjects can be followed up regularly, have good communication with the researchers, and complete the study in accordance with the provisions of the 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)
• A patient with a previous malignancy (other than cured basal cell carcinoma of the skin or squamous cell carcinoma) should not participate in the study unless she had a complete response for at least 5 years prior to enrollment and was not expected to require additional antitumor therapy during the study period;
• 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
• Have active, known history of autoimmune diseases, including but not limited to systemic lupus erythematosus (sle), psoriasis, rheumatoid arthritis, inflammatory bowel disease, hashimoto's thyroiditis, except: type I diabetes, only by hormone replacement therapy can control the hypothyroidism, no systemic treatment of skin diseases, such as vitiligo, and has celiac disease control;
• Complications that require immunosuppressive drug therapy or systemic treatment at immunosuppressive doses (prednisone \> 10mg/ day or equivalent dose of the same drug); In the absence of active autoimmune disease, inhaled or topical steroids and doses \> 10mg/ day of prednisone or equivalent doses of similar drugs are permitted;
• Uncontrolled hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg) or pulmonary hypertension or unstable angina; Myocardial infarction or bypass or stent surgery within 6 months before administration; A history of chronic heart failure that meets New York Heart Association (NYHA) criteria of grade 3-4; Valvular disease of clinical significance; Severe arrhythmias requiring treatment, including QTc interval ≥470 ms (as calculated by Fridericia formula); Left ventricular ejection fraction (LVEF) \< 50%; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration;
• Other serious medical diseases, including but not limited to: uncontrolled diabetes, active digestive ulcer, active bleeding, etc.;
• Actively infected persons requiring systemic treatment;
• Previously or currently infected with active TUBERCULOSIS;
• Previous history of interstitial lung disease;

Sponsors & Collaborators

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

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

• Ke-qiang zhang

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-qiang zhang

CONTACT

130 5419 6067; zhangkeqiang@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 17 cycles of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until one year.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 9, 2021
• Study Start: December 1, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-11

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