Solid TumorPhase 2NCT04569916
Radiotherapy Combined With Irinotecan and Apatinib Followed by PD-1 Antibody and Apatinib for Advanced Solid Tumors
A Phase 2 study testing radiotherapy, irinotecan liposome and apatinib in people with Solid Tumor, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
An exploratory study to evaluate for the treatment of advanced solid tumors that failed standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- radiotherapy, irinotecan liposome and apatinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, both men and women;
- Eastern Cooperative Oncology Group performance status 0-1;
- Pathologically confirmed recurrent or metastatic solid tumors (pancreatic cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck tumors, gastric cancer, etc.) that failed, couldn't tolerate or lacked standard treatments;
- According to the response evaluation criteria in solid tumor (RECIST 1.1), at least two measurable lesion for radiotherapy; for patients with brain metastases, there must be at least one metastasis outside the brain;
- Expected survival period ≥ 12 weeks;
- The main organ function and bone marrow function are normal, meeting the following requirements:
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- Hemoglobin ≥ 90 g / L; (No blood transfusion within 14 days)
- Absolute neutrophil count ≥1.5×109/L;
- platelet count ≥ 90 × 109 / L;
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN; if there is liver metastasis, ALT and AST ≤ 5 times ULN;
- creatinine ≤ 1.5 times ULN;
- Left ventricular ejection fraction (LVEF) ≥ 50%; QTc male <450ms, female <470ms;
- Patients who have not received anticoagulant therapy have an international normalized ratio (INR) of ≤1.5 and partial thromboplastin time (APTT) ≤1.5 times ULN. Patients receiving total or parenteral anticoagulant therapy should be stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment;
- Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment, and voluntarily use the appropriate method for contraception during the observation period and within 3 months after the last administration of the study drug; for men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug.
- The toxicity of receiving pre-treatment has been restored to ≤grade 1 (if the patient received surgery, the wound should be completely healed);
- Patients voluntarily participate in and sign informed consent, and they are expected to have good compliance and can cooperate with the research according to the program requirements.
Who cannot join
- Received any kind of anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy, and immunotherapy, or participate in another interventional clinical trial;
- Major surgery was performed within 4 weeks before enrollment (except for minor surgery, such as placement of vascular access); surgical fixation of the bone lesions to be irradiated is required, and mechanical stabilization is indicated;
- There is a third interstitial fluid (such as a large amount of pleural effusion or ascites) that has clinical symptoms and cannot be controlled by drainage or other methods;
- Even after medical treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg)
- Suffering from uncontrolled clinical symptoms or diseases of the heart, such as (1) New York Heart Association II and above heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant patients with supraventricular or ventricular arrhythmia requiring clinical intervention;
- Patients with any active autoimmune disease or history of autoimmune disease, including interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, and hypothyroidism (hypothyroidism can be included after hormone replacement therapy), except for patients with vitiligo or childhood asthma that has been completely relieved and does not require any intervention after adulthood. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
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- People with congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of the analytical method) or co-infection with hepatitis B and C;
- Severe infection within 4 weeks before the first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5 °C during screening/before first dose;
- Events of arterial or venous thrombosis occurring within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Have had or have other systemic malignancies in the last 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer);
- Those who are known to be allergic to any study drug;
- Pregnant patients, lactating patients, or patients with reproductive ability are not willing to take effective contraceptive measures;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Known uncontrolled or symptomatic active central nervous system (CNS) metastases, manifested by clinical signs, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth;
- Patients who are unable to swallow the study drug, such as patients with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction, and other various factors that affect drug administration and absorption;
- Other circumstances that the investigator believes are not suitable for inclusion. If accompanied by family or social factors, it will affect the safety of the subject or the collection of data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital, The Affiliated of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Jie Shen, Doctor, 13675101127, shenjie2008nju@163.com
Baorui Liu, Doctor
About this study
Official title: An Exploratory Study to Evaluate Radiotherapy Combined With Irinotecan Liposome and Apatinib Followed by PD-1 Antibody and Apatinib for the Treatment of Advanced Solid Tumors That Failed Standard Treatments
An exploratory study to evaluate for the treatment of advanced solid tumors that failed standard treatments.
Read the detailed description
This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib.
- Conditions
- Solid Tumor
- Being tested
- radiotherapy, irinotecan liposome, apatinib, PD-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyRadiation
radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
irinotecan liposomeDrug
radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
apatinibDrug
Also called Apatinib Mesylate Tablets
radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
PD-1 antibodyDrug
radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib Receives: Radiation: radiotherapy; Drug: irinotecan liposome; Drug: apatinib; Drug: PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 2 years
Secondary outcomes (5)
Disease Control Rate
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 2 years
Clinical benefit rate
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 2 years
Correlation between immune microenvironment parameters of target lesions and efficacy
Evaluated by researchers based on the RECIST 1.1 standard
Measured: 2 years
Drug-related Adverse Event
Evaluated by researchers
Measured: 2 years
Drug-related Serious Adverse Event
Evaluated by researchers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baorui Liu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Baorui Baorui Liu, Doctor, Principal investigator, Nanjing Drum Tower Hospital, The Affiliated of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569916
- Sponsor's protocol ID
- IIT-RT-IRI-SHR1210-APA
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Shen J, Yan J, Du J, Li X, Wei J, Liu Q, Yong H, Wang X, Chang X, Ding Z, Sun W, Liu C, Zhu S, Guo J, Li H, Liu Y, Zhang W, Liu Z, Li R, Liu B. Multicenter, single-arm, phase II study (CAP) of radiotherapy plus liposomal irinotecan followed by camrelizumab and anti-angiogenic treatment in advanced solid tumors. Front Immunol. 2023 Mar 28;14:1133689. doi: 10.3389/fimmu.2023.1133689. eCollection 2023.
PubMed 37056765
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate Radiotherapy Combined With Irinotecan Liposome and Apatinib Followed by PD-1 Antibody and Apatinib for the Treatment of Advanced Solid Tumors That Failed Standard Treatments
- ClinicalTrials.gov ID
- NCT04569916
- Acronym / sponsor ID
- IIT-RT-IRI-SHR1210-APA
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An exploratory study to evaluate for the treatment of advanced solid tumors that failed standard treatments.
Detailed description
This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Radiation: radiotherapy, Drug: irinotecan liposome, Drug: apatinib, Drug: PD-1 antibodyradiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18-70 years old, both men and women;
- Eastern Cooperative Oncology Group performance status 0-1;
- Pathologically confirmed recurrent or metastatic solid tumors (pancreatic cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, head and neck tumors, gastric cancer, etc.) that failed, couldn't tolerate or lacked standard treatments;
- According to the response evaluation criteria in solid tumor (RECIST 1.1), at least two measurable lesion for radiotherapy; for patients with brain metastases, there must be at least one metastasis outside the brain;
- Expected survival period ≥ 12 weeks;
Key exclusion criteria (16 listed)
- Received any kind of anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy, and immunotherapy, or participate in another interventional clinical trial;
- Major surgery was performed within 4 weeks before enrollment (except for minor surgery, such as placement of vascular access); surgical fixation of the bone lesions to be irradiated is required, and mechanical stabilization is indicated;
- There is a third interstitial fluid (such as a large amount of pleural effusion or ascites) that has clinical symptoms and cannot be controlled by drainage or other methods;
- Even after medical treatment, hypertension is still poorly controlled (continuous increase in systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg)
- Suffering from uncontrolled clinical symptoms or diseases of the heart, such as (1) New York Heart Association II and above heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant patients with supraventricular or ventricular arrhythmia requiring clinical intervention;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapyradiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib | Radiation | treatment group |
| irinotecan liposomeradiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib | Drug | treatment group |
| apatinibAlso: Apatinib Mesylate Tabletsradiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib | Drug | treatment group |
| PD-1 antibodyradiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib | Drug | treatment group |
Primary outcome
Objective Response Rate
Time frame: 2 years
Evaluated by researchers based on the RECIST 1.1 standard
5 secondary outcomes
Disease Control Rate
Time frame: 2 years
Clinical benefit rate
Time frame: 2 years
Correlation between immune microenvironment parameters of target lesions and efficacy
Time frame: 2 years
Drug-related Adverse Event
Time frame: 2 years
Drug-related Serious Adverse Event
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 37056765Shen J, Yan J, Du J, Li X, Wei J, Liu Q, Yong H, Wang X, Chang X, Ding Z, Sun W, Liu C, Zhu S, Guo J, Li H, Liu Y, Zhang W, Liu Z, Li R, Liu B. Multicenter, single-arm, phase II study (CAP) of radiotherapy plus liposomal irinotecan followed by camrelizumab and anti-angiogenic treatment in advanced solid tumors. Front Immunol. 2023 Mar 28;14:1133689. doi: 10.3389/fimmu.2023.1133689. eCollection 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baorui Baorui Liu, Doctor principal investigator
Nanjing Drum Tower Hospital, The Affiliated of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy, irinotecan liposome and apatinib in people with Solid Tumor, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Shen, Doctor (13675101127, shenjie2008nju@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.