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A Phase II clinical study of SHR-1701 combined with albumin paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

A Phase II clinical study of SHR-1701 combined with albumin paclitaxel and carboplatin in the treatment of advanced non-small cell lung cancer with malignant pleural effusion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062197
Enrollment
Unknown
Registered
2022-07-29
Start date
2023-02-08
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer with malignant pleural effusion

Interventions

1:SHR-1701 combined with albumin paclitaxel and carboplatin

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participate voluntarily and sign informed consent with good compliance and can cooperate with diagnosis, treatment and follow-up; 2. Age >=18, male or female; 3. Diagnosis of NSCLC by histopathological and/or cytological examination, clinical stage IV (according to the TNM Staging System for Lung Cancer, 8th Edition of the International Association for the Study of Lung Cancer and the Joint Committee on American Classification of Cancer), with symptomatic malignant pleural effusion; 4. ECOG performance score 0-1 after discharge of pleural effusion; 5. Expected survival >=3 months; 6. The functions of the main organs are basically normal.

Exclusion criteria

Exclusion criteria: 1. Untreated BMS (patients who have received prior treatment for BMS [radiotherapy or surgery], who have been stable for at least 4 weeks on pre-randomized imaging and have stopped systemic hormone therapy [prednisone > 10mg/ day or other hormone equivalents] and who have no clinical symptoms can be enrolled); 2. With meningeal metastasis and spinal cord compression; 3. Bilateral pleural effusion is malignant pleural effusion; 4. Non-retractable pleural effusion (that is, the lung is still in the collapse state after thoracic tube drainage and cannot be retracted); Encapsulated compartmentalized pleural effusion; 5. Chest infection; There was skin infection at the site of thoracic catheterization; 6. Has not recovered to grade <=1 from any adverse event caused by any intervention prior to initial administration (except for hypotricia, hearing loss, and neurologic or endocrine disorders requiring substitution therapy, grade <=2); 7. Other conditions that the researcher considers inappropriate for inclusion.

Design outcomes

Primary

MeasureTime frame
Pleural fixation rate;Progression-free survival, PFS;

Secondary

MeasureTime frame
Objective response rate, ORR;1 year overall survival rate;Change in dyspnea score;Safety;

Countries

China

Contacts

Public ContactTian Panwen

West China Hospital of Sichuan University

mrascend@163.com+86 189 8060 6625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026