Trial Title:
Toripalimab Combined with Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
NCT ID:
NCT06127303
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Disease Progression
Immunomodulating Agents
Conditions: Keywords:
Oligo-progression
Toripalimab
Cryoablation
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after
cryoablation, until occurrence of termination event specified in the protocol.
Arm group label:
Toripalimab Combined with Cryoablation
Other name:
Immunotherapy
Intervention type:
Other
Intervention name:
Cryoablation
Description:
The ablation was performed on the first day of each cycle, and the target lesions were
comprehensively screened for cryoablation based on the location and size of the lesions.
Arm group label:
Toripalimab Combined with Cryoablation
Summary:
Immunotherapy with programmed death-1(PD-1) inhibitors is now standard therapy for
first-line use in patients with driver-negative advanced NSCLC, whether as single-agent
or in combination with chemotherapy. After progression of first-line immunotherapy, NSCLC
patients may be treated with chemotherapy, radiotherapy or targeted therapies, among
others. Recently, Immune Checkpoint inhibitors (ICIs) rechallenge has become a highly
anticipated option. Although the objective response rate of the ICIs rechallenge patients
has decreased substantially compared with the efficacy of the first ICI treatment, nearly
50% of patients can regain disease control.
Cryoablation is a minimally invasive technique that utilizes very low temperature to
eliminate viable tumour cells in target tissues. It has been reported that ablation can
enhance immune response.
The objective of this study was to evaluate the efficacy and safety of toripalimab (PD-1)
in combination with cryoablation in the treatment of oligometastatic driver-negative
advanced NSCLC after first-line immunotherapy progress.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary participation and written informed consent;
- histologically or cytologically confirmed advanced metastatic (stage IV) non-small
cell lung cancer;
- Patients with negative driver genes who develop oligoprogression after receiving
standard first-line therapy. The oligoprogression is defined as: 1-5 metastatic
lesions, and no more than 3 organs;
- Age 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months;
- At least one measurable lesion;
- Patients were willing to provide adequate blood and tissue samples；
- Patients had adequate hematologic, renal, and liver function;
- International normalised ratio (INR) ≤1.5 and partial thromboplastin time (PTT or
aPTT) ≤1.5 x ULN within 7 days prior to study treatment;
- The woman patients of childbearing age who must agree to take contraceptive methods
during the research;
- The man patients who must agree to take contraceptive methods during the research
and within another 6 months after it.
Exclusion Criteria:
- cytologically or histologically confirmed combination with small cell lung cancer
component or sarcomatoid element;
- Previously received targeted therapy for advanced NSCLC (including osimertinib,
erlotinib, crizotinib, etc);
- Had undergone major surgical operations or had not fully recovered from previous
operations within 3 weeks before enrollment;
- Known active nervous system (CNS) metastases and/or carcinomatous meningitis;
- Spinal cord compression for which operation and/or radical radiotherapy has not been
given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment
after treatment for previously diagnosed spinal cord compression;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage; patients with stable symptoms after drainage can be enrolled;
- History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating
bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active
pneumonia during chest CT scanning for screening;
- Clinically uncontrolled active infection, including but not limited to acute
pneumonia;
- Uncontrollable major epileptic seizure or superior vena cava syndrome;
- Previous or current co-occurrence of other malignancies (excluding controllable
non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of
the breast or cervix, superficial bladder cancer, or other carcinoma in situ);
- Known hepatic diseases of clinical significance, including active viral hepatitis,
alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary
liver disease;
- Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within
one year prior to screening;
- Use of systemic immunosuppressive therapy for any active autoimmune disease within
two years prior to Day 1 of the 1st cycle;
- Vaccination of live-virus vaccine within 30 days after the start of planned
treatment; Inactivated seasonal influenza vaccine was permitted;
- Patients has HIV-positive;
- Patients judged by the investigator to be inappropriate as a subject of this study.
- History of severe allergic, quasi-allergic, or other hypersensitive reactions to
chimeric or humanized antibodies or fusion proteins;
- Known allergy to biological drugs produced from Chinese hamster ovary cells, or to
citrate monohydrate, sodium citrate dihydrate, mannitol, polysorbate (components of
the study drug);
- Patients who have previously received allogeneic stem cells or parenchymal organ
transplants.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ziming Li, Doctor
Phone:
0086-13764590226
Email:
liziming1980@163.com
Facility:
Name:
Shanghai General Hospital, Shanghai Jiaotong University
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aihua Bao, MD,PHD
Phone:
+8613402016536
Email:
aihuabao312@126.c0m
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong Zhang, MD,PHD
Phone:
+8615000229853
Email:
zhang.yong@zs-hospital.sh.cn
Start date:
April 2, 2024
Completion date:
April 2, 2028
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127303
