First Line Sintilimab Combined With Anlotinib and Platinum Doublet Chemotherapy in Malignant Pleural Mesothelioma

NCT05188859 | Recruiting Phase 2

• 1 other identifier: NCC2950
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Mesothelioma, Malignant; Mesothelioma, Malignant Pleural; Mesothelioma Malignant Advanced

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate（ORR）according to mRECIST 1.1 standard

  6 months after the final enrollment

Secondary Outcomes (7)

• DOR

  24 months

• DCR

  24 months

• PFS

  24 months

• OS

  24 months

• AE

  24 months

Study Arms (1)

Treatment

EXPERIMENTAL

Regimen: 1. Sintilimab, 200mg, ivgtt d1, q3w, on a 21-day cycle, for a maximum of 24 months; 2. Anlotinib, 12mg, po, qd, d1-14, q3w, on a 21-day cycle, for a maximum of 24 months; 3. Pemetrexed, 500mg/m², ivgtt , d1, q3w, on a 21-day cycle; 4. Cisplatin, 75mg/m2 , ivgtt, d1, q3w/Carboplatin, AUC 5.0, ivgtt, d1, q3w, on a 21-day cycle, 4-6 cycles.

Drug: Sintilimab+Anlotinib+Pemetrexed+Cisplatin

Interventions

Sintilimab+Anlotinib+Pemetrexed+Cisplatin DRUG

Sintilimab 200mg+Anlotinib 12mg+Pemetrexed 500mg/m²+Cisplatin 75mg/m2

Also known as: S+A+PC

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG score 0-1 points;
• The expected survival time was \> 3 months,
• For adequate organ function, the patients need to meet the following laboratory indexes:
• the absolute value of neutrophils (ANC) ≥ 1.5x109/L without granulocyte colony stimulating factor in the past 14 days.
• in the last 14 days without blood transfusion, the platelet count was ≥ 100x109/L.

You may not qualify if:

• 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.
• Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
• Symptomatic or uncontrolled brain metastasis;
• Active hemoptysis (at least 2.5ml or 1/2 teaspoon of blood was spit out at a time) 3 months before the first study drug administration;
• Imaging showed that there were tumors invading / infiltrating large blood vessels or bleeding tendency assessed by researchers or radiologists;
• Received major surgery (except for surgery for the purpose of biopsy) within 4 weeks before the first study drug administration, or is expected to undergo major surgery during the study period;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

Shanxi Provincial Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University

Taiyuan, Shanxi, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wang, MD,PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang, MD,PhD

CONTACT

8610-87788029; zlhuxi@163.com

Duan, MD

CONTACT

8610-87788029; duanjianchun79@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Oncology

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)