CompletedPhase 2

Phase II, Single-arm Exploratory Clinical Study of Tislelizumab Combined With Anlotinib in the Treatment of Advanced Pulmonary Pleomorphic Carcinoma

China29 participantsStarted 2021-08-17

Plain-language summary

Evaluate the efficacy and safety of tislelizumab in combination with anlotinib in patients with stage III and IV PSC .

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects voluntarily participate in the study and sign informed consent;
. Male or female patients aged between 18 and 80 years;
. Patients with stage III or IV pulmonary sarcomatoid carcinoma that has been histologically or cytologically confirmed as inoperable or intolerant to radiotherapy and has at least one measurable lesion (according to RECIST V1.1 criteria);EGFR and ALK driver genes were negative.
. Previous systemic antitumor therapy ≤2 times;
. ECOG score: 0,1;
. Life expectancy ≥12 weeks;
. The main organs function normally, that is, they meet the following criteria:

Exclusion criteria

. Patients with symptomatic brain metastasis, cancerous meningitis, spinal cord compression, or diseases of the brain or pia meningeal revealed by imaging CT or MRI examination during screening (patients with brain metastasis who had completed treatment 4 weeks before enrollment and had stable symptoms without progression could be enrolled, but were confirmed to have no symptoms of cerebral hemorrhage by craniocerebral MRI, CT or venography evaluation);
. The patient is participating in other clinical studies (excluding non-interventional studies) or less than 4 weeks after the completion of treatment in the previous clinical study;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective Response Rate, ORR

Timeframe: Until the disease progression, an average of 1 year

Trial details

NCT IDNCT05375734

SponsorSecond Affiliated Hospital of Nanchang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-25

View on ClinicalTrials.gov More Pulmonary Pleomorphic Carcinoma trials