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
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Cervical Cancer
- Sponsor
- Hunan Cancer Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Complete remission rate (CR)
- Last Updated
- 4 years ago
Overview
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Camrelizumab , Cisplatin or Carboplatin
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.
Intervention: Camrelizumab
Camrelizumab , Cisplatin or Carboplatin
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.
Intervention: Cisplatin or Carboplatin
Outcomes
Primary Outcomes
Complete remission rate (CR)
Time Frame: immediately after the concurrent chemoradiation
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 '%'.
Secondary Outcomes
- Progression-free survival (PFS)(1 year)
- 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)