NCT05188859
Recruiting
Phase 2
Study of Sintilimab Combined With Anlotinib and Platinum-Containing Dual-Agent Chemotherapy as First Line Therapy in Malignant Pleural Mesothelioma: A Single Arm, Open-label, Prospective Phase II Trial
Cancer Institute and Hospital, Chinese Academy of Medical Sciences2 sites in 1 country29 target enrollmentStarted: September 1, 2024Last updated:
InterventionsSintilimab+Anlotinib+Pemetrexed+Cisplatin
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- ORR
Overview
Brief Summary
This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma.
Detailed Description
Patients with advanced or metastatic (stage IIIB or IV) pleural mesothelioma who had not received previous systemic therapy were screened for eligible subjects to be eligible for enrollment after signing an written informed consent to receive Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other antineoplastic therapy, death or other situations for which protocol specified treatment should be discontinued (whichever occurs first). The maximum duration of treatment with Sintilimab is 24 months (in general).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign written informed consent before implementing any trial-related procedures;
- •Age ≥ 18 years old.
- •Histologically confirmed, unresectable or inoperable or locally advanced (IIIB stage), recurrent or metastatic (IV stage) malignant pleural mesothelioma.
- •According to the modified version of the evaluation criteria for the efficacy of solid tumor (mRECIST1.1 ), patients have at least one imaging lesion can be measured;
- •Patients have not received any systemic anti-tumor therapy for advanced/metastatic diseases in the past. Patients who have previously received platinum-containing adjuvant / neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, such as the interval between disease progression or recurrence and the end of the last chemotherapeutic drug treatment at least 6 months, are allowed to be enrolled in this study.
- •Patients with brain metastasis who are asymptomatic or stable after local treatment are allowed to be included in this study, as long as they meet the following conditions:
- •There are measurable lesions outside the central nervous system.
- •No central nervous system symptoms or no aggravation within at least 2 weeks.
- •Those who do not need glucocorticoid therapy or stop glucocorticoid therapy within 7 days before the first study drug administration.
- •Patients are allowed to receive palliative radiotherapy, but the end of radiotherapy is within 7 days before the administration of the first study drug.
Exclusion Criteria
- •Diagnosis of malignant diseases other than malignant pleural mesothelioma (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and / or radical resection of carcinoma in situ) within 5 years before the first administration
- •Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
- •Previous usage of the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
- •Within 2 weeks before the first administration, they received systemic systemic therapy with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for controlling local use of pleural effusion)
- •Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
- •The patients are received systemic glucocorticoid therapy (excluding nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration.
- •Note: The use of physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent drugs) is allowed;
- •There are clinically uncontrollable pleural effusion / ascites (patients who do not need drainage or stop drainage for 3 days without a significant increase in effusion can be enrolled in the group)
- •Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- •Those who are known to be allergic to the active ingredients or excipients of Sintilimab in this study.
Arms & Interventions
Treatment
Experimental
Regimen:
- Sintilimab, 200mg, ivgtt d1, q3w, on a 21-day cycle, for a maximum of 24 months;
- Anlotinib, 12mg, po, qd, d1-14, q3w, on a 21-day cycle, for a maximum of 24 months;
- Pemetrexed, 500mg/m², ivgtt , d1, q3w, on a 21-day cycle;
- Cisplatin, 75mg/m2 , ivgtt, d1, q3w/Carboplatin, AUC 5.0, ivgtt, d1, q3w, on a 21-day cycle, 4-6 cycles.
Intervention: Sintilimab+Anlotinib+Pemetrexed+Cisplatin (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 6 months after the final enrollment
Objective Response Rate（ORR）according to mRECIST 1.1 standard
Secondary Outcomes
- AE(24 months)
- SAE(24 months)
- Lab indicators(24 months)
- DOR(24 months)
- DCR(24 months)
- PFS(24 months)
- OS(24 months)
Investigators
Jie Wang
Chief of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Sites (2)
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