Clinical trial · Interventional
Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
NCT06416930CI-TRIAL-00077232not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab Combined with chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab combined with chemotherapy
- description
- All subjects in the group will be treated with Cadonilimab plus gemcitabine / vinorelbine / pemetrexed once every three weeks.
- interventionNames
- Drug: Cadonilimab Combined with chemotherapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 2 year
- description
- defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
Secondary outcomes (5)
- measure
- Disease Control Rate (DCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed advanced or metastatic pleural mesothelioma; 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy. 4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. 5. Adequate haematological, renal and liver function. Exclusion Criteria: 1. Primary mesothelioma of peritoneum, pericardium and testes 2. Active, untreated central nervous system (CNS) metastasis. 3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment. 4. Known active autoimmune diseases. 5. Presence of other uncontrolled serious medical conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.