Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-… (NCT05926700) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment
China27 participantsStarted 2024-02-28
Plain-language summary
Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥18 years .
✓. Voluntarily sign written informed consent.
✓. Advanced or unresectable soft tissue sarcomas confirmed by pathology mainly include liposarcoma, leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, fibrosarcoma, pleomorphic rhabdomyosarcoma, acinar soft tissue sarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, sarcoma after radiotherapy, etc.
✓. Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months.
✓. According to RECIST 1.1, there was at least one measurable tumor lesion.
✓. ECoG score 0 or 1.
✓. The expected survival was ≥ 3 months.
✓. The main organs function well:
Exclusion criteria
✕. Participated in the treatment of experimental drugs or used experimental devices within 4 weeks before the first administration of candonilimab.
✕. Had other active malignancies within 3 years before enrollment. Except for locally curable malignant tumors (manifested as cured), such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, endometrial, cervical or breast cancer in situ.
What they're measuring
1
Progression-Free-Survival （PFS）
Timeframe: through study completion，an average of 1 year
Trial details
NCT IDNCT05926700
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. Another clinical study is enrolled at the same time, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study (defined as the time from the first medication to the last medication of the previous clinical study is more than 4 weeks or the five half lives of the study drug are more than 5, whichever is the longest).
✕. Active autoimmune diseases requiring systemic treatment within two years before the start of study treatment, or autoimmune diseases that may recur or are planned to be treated according to the judgment of the investigator; The following exceptions: skin diseases that do not need systematic treatment (such as vitiligo, alopecia, psoriasis or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires a stable dose of hormone replacement therapy; Well controlled type I diabetes; Subjects whose asthma in childhood has been completely relieved and who do not need any intervention after adulthood; The investigator judged that the disease would not recur without external triggers.
✕. Inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea) with active or requiring clinical treatment.
✕. The subject required systemic treatment with corticosteroids (\>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days after taking the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal gland replacement doses of \>10mg daily prednisone equivalent were allowed. Subjects were allowed to use topical, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). Physiological alternative doses of systemic corticosteroids are allowed, even if \>10 mg / day of prednisone equivalent. Short term use of corticosteroids is allowed to prevent (such as contrast allergy) or treat non autoimmune diseases (such as delayed type hypersensitivity caused by contact allergens).
✕. He has previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy and other treatments targeting tumor immune mechanism.
✕. The best swelling evaluation result of patients who had received previous treatment with anlotinib was PD, or SD ≤ 12 weeks.