Camrelizumab Combined With Chemotherapy and Apatinib for Extrapulmonary Neuroendocrine Carcinomas (NCT05142865) | Clinical Trial Compass
UnknownPhase 2
Camrelizumab Combined With Chemotherapy and Apatinib for Extrapulmonary Neuroendocrine Carcinomas
China30 participantsStarted 2022-01-14
Plain-language summary
This is an open-label，single-arm, phase II exploratory study that evaluates the efficacy and safety of Camrelizumab combined with Chemotherapy （carboplatin or cisplatin + etoposide）and Apatinib as First Line treatment in Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas（EP-NEC）
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Pathologically or cytologically diagnosed as locally advanced or metastases extrapulmonary neuroendocrine carcinoma that cannot be surgically removed.
✓. Aged 18-75，male and female
✓. Patients who have not received systemic treatment for advanced or metastatic EP-NEC . Subjects who have previously received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy or radiochemotherapy) for EP-NEC must have completed the last dose at least 6 months before enrollment . Palliative radiotherapy is permitted, but it must be completed at least 2 weeks prior to the study treatment. The lesions in the irradiation field cannot be used as target lesions for efficacy evaluation, and radiotherapy-related adverse reactions must be restored to at least Grade 0-1.
✓. ECOG PS 0-1.
✓. At least 1 measurable lesion according to RECIST criteria.
✓. Adequate organ and bone marrow function, defined as follows:
✓. Subjects must agree and have signed the informed consent form, be willing and able to follow the scheduled visits, study treatment, laboratory tests, and other study procedures.
✓. Life expectancy \> 12 weeks.
Exclusion criteria
✕. Presence of known uncontrolled or symptomatic active central nervous system (CNS) metastasis, manifested as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth. For CNS metastases that have been adequately treated, and neurological symptoms can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to CNS treatment), they can be included . In addition, subjects must stop corticosteroids or receive a stable dose of ≤ 10 mg/d or a gradually decreasing dose of prednisone (or an equivalent dose of other corticosteroids) at least 2 weeks before enrollment.
What they're measuring
1
Overall response rate （ORR）
Timeframe: 2 years
Trial details
NCT IDNCT05142865
SponsorHuazhong University of Science and Technology
✕. Have received the following treatments or drugs before enrollment:
✕. Prior malignancy within 3 years, except adequately treated basal cell carcinoma or squamous cell skin cancer ,superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid cancer.
✕. Prescence of any active, known or suspected autoimmune diseases. Subjects who are in a stable state and do not require systemic immunosuppressive therapy are allowed, such as type I diabetes, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic therapy (eg, vitiligo, psoriasis disease and hair loss).
✕. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies that act on T cell costimulation or checkpoint pathways.
✕. Prescence of clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment; 6 before enrollment Arterial/venous thrombosis events that occurred within a month, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
✕. Have major vascular disease (for example, an aortic aneurysm that requires surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the start of study treatment.
✕. Severe, unhealed or dehisced wounds and active ulcers or untreated fractures.