Advanced Solid TumorPhase 2/3NCT05809336
Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
A Phase 2/3 study testing Inosine 0.2g orally 3 times/day and PD-1/PD-L1 inhibitor ,chemotherapy/targeting in people with Advanced Solid Tumor, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors .One group was the inosine group , the other group was the non-inosine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Inosine 0.2g orally 3 times/day and PD-1/PD-L1 inhibitor ,chemotherapy/targeting
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Oct 2022
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed unresectable locally advanced, recurrent or metastatic solid tumors
- Age 18 years old - 75 years old
- ECOG score of ≤ 2
- Time to end of palliative treatment for localized lesions (non-target lesions) was >3 weeks from randomization start time, At least one measurable lesion or assessable lesion according to RECIST v1.1
- Can provide archived pathological tissues or fresh pathological tissues for PD-L1, MMR/MSI, TMB testing within 6 months from the signing of the informed consent for screening and can obtain the test results
- Adequate organ and bone marrow function, defined as follows: 1) Blood count: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin level (HGB) ≥ 9.0 g/dL. 2) Liver function: patients without liver metastases require: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal ( ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. patients with liver metastases required: TBIL ≤1.5×ULN; ALT and AST ≤5×ULN. 3) renal function: creatinine clearance (Ccr) ≥50mL/min (calculated using the Cockcroft/Gault formula): female: Ccr = (140-years-old) × body weight (kg) × 0.85; men: Ccr = (140-years-old) × body weight (kg) × 1.00. 4) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN
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- Expected survival time ≥ 12 weeks
- Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 6 months after the treatment period
- Sign the written informed consent
Who cannot join
- Signs of active bleeding or perforation
- History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection, Crohn's disease, ulcerative colitis
- Hepatic metastatic focal load of approximately 50% or more of the entire liver volume
- Antibiotic was used within 2 weeks before study treatment
- Received systemic antitumor therapy with herbs or immunomodulatory drugs (including thymidine, interferon, interleukin, etc.) within 2 weeks before the first dose.
- immunosuppressive drugs was used within 4 weeks before study treatment, excluding topical glucocorticoids or physiologic doses of systemic glucocorticoids (i.e., no more than 10mg/day of prednisone or equivalent doses of other glucocorticoids) of nasal spray, inhalation, or other routes, or glucocorticoid for the prevention of contrast allergy
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- Interstitial lung disease requiring glucocorticoid therapy
- Active, known or suspected autoimmune disease or history of the disease within the last 2 years (patients with vitiligo, psoriasis, alopecia or Grave's disease not requiring systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes requiring only insulin replacement therapy may be enrolled)
- Symptomatic congestive heart failure (New York Heart Association class -≥3) or symptomatic or poorly controlled arrhythmias
- standard treatment could not uncontrollarterial hypertension (systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100).
- Any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, within 6 months prior to enrollment in treatment
- History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to enrollment
- Known active tuberculosis
- Known history of case type immunodeficiency virus infection
- Positive hepatitis B surface antigen and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test ≥ 1×104 copies/mL (or HBV-DNA quantification ≥ 2000 units/ml); active hepatitis C
- History of other primary malignancies, except: malignancies in complete remission for at least 5 years prior to enrollment and requiring no other treatment during the study period; adequately treated non-melanoma skin cancer or malignant freckled nevus with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence
- Patients who, in the judgment of the investigator, are otherwise likely to interfere with the conduct of the clinical study, who may not be able to comply with the protocol or who are unable to cooperate, or who are a risk to the study This study was approved by the Clinical Investigation Ethics Committee of Beijing Friendship Hospital, Capital Medical University, and was conducted in accordance with the Declaration of Helsinki. All patients signed informed consent forms for data collection and study purposes
Trial locations and contacts
1 site in 1 country.
About this study
We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors .One group was the inosine group , the other group was the non-inosine group.The treatment regimen of inosine group : inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine group : PD-1/PD-L1 inhibitor ± chemotherapy/targeting.The primary study endpoints were overall survival (OS) and progression-free survival PFS, and the secondary study endpoints were objective remission rate (ORR) and disease control rate (DCR) comparing the two groups.
Read the detailed description
We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors.One group was the inosine group , the other group was the non-inosine group. A total of 172 patients with advanced malignant solid tumors were collected from Capital Medical University Beijing Friendship Hospital, and randomly assigned to two groups according to 1:1, 86 patients in the inosine group and 86 patients in the non-inosine group. The regimen of inosine treatment group was: inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine treatment group was: PD-1/PD-L1 inhibitor ±chemotherapy/targeting,every 2 or 3 weeks protocol ,until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit.Anti-tumor efficacy is evaluated every 2/3 cycles (every 6 weeks) based on computed tomography (CT) or magnetic resonance imaging (MRI) results and their tumor markers, according to RECIST v1.1 criteria.
Inosine tablets were purchased from Tianjin Jinshi, dosage: 0.2g orally 3 times/day, PD-1/PD-L1 inhibitors, chemotherapy and targeted combination therapy regimens were developed by the investigators according to the NCCN guidelines and CSCO guidelines and the patient's condition and its staging.
- Conditions
- Advanced Solid Tumor
- Being tested
- Inosine 0.2g orally 3 times/day, PD-1/PD-L1 inhibitor ,chemotherapy/targeting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inosine 0.2g orally 3 times/dayDrug
Also called Camrelizumab for injection, Sintilimab injection, Penpulimab injection, Tislelizumab injection
inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting,
PD-1/PD-L1 inhibitor ,chemotherapy/targetingDrug
Also called Camrelizumab for injection, Sintilimab injection, Penpulimab injection, Tislelizumab injection
PD-1/PD-L1 inhibitor ± chemotherapy/targeting
| Study group | Role | What they receive |
|---|---|---|
| inosine group | Experimental | Participants will receive inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting,every 2 or 3 weeks, until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit Receives: Drug: Inosine 0.2g orally 3 times/day |
| non-inosine group | Active comparator | Participants will receive PD-1/PD-L1 inhibitor ± chemotherapy/targeting, every 2 or 3 weeks .until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit Receives: Drug: PD-1/PD-L1 inhibitor ,chemotherapy/targeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Time from randomization grouping to death from any cause
Measured: 36 months
progression-free survival (PFS)
Time from randomization grouping to the first recorded disease progression or death from any cause
Measured: 36 months
Secondary outcomes (2)
objective remission rate(ORR) [ Time Frame: Up to 36 months ]
Proportion of subjects with best overall efficacy assessed as CR and PR
Measured: 36 months
disease control rate (DCR)
Proportion of subjects with best overall efficacy assessed as CR, PR and SD
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 May 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809336
- Sponsor's protocol ID
- Beijing inosine
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao H, Zhang W, Lu Y, Dong Y, He Z, Zhen H, Li Q. Inosine enhances the efficacy of immune-checkpoint inhibitors in advanced solid tumors: A randomized, controlled, Phase 2 study. Cancer Med. 2024 Sep;13(17):e70143. doi: 10.1002/cam4.70143.
PubMed 39267574
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05809336
- Acronym / sponsor ID
- Beijing inosine
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Apr 2023 (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.
We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors .One group was the inosine group , the other group was the non-inosine group.The treatment regimen of inosine group : inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine group : PD-1/PD-L1 inhibitor ± chemotherapy/targeting.The primary study endpoints were overall survival (OS) and progression-free survival PFS, and the secondary study endpoints were objective remission rate (ORR) and disease control rate (DCR) comparing the two groups.
Detailed description
We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors.One group was the inosine group , the other group was the non-inosine group. A total of 172 patients with advanced malignant solid tumors were collected from Capital Medical University Beijing Friendship Hospital, and randomly assigned to two groups according to 1:1, 86 patients in the inosine group and 86 patients in the non-inosine group. The regimen of inosine treatment group was: inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine treatment group was: PD-1/PD-L1 inhibitor ±chemotherapy/targeting,every 2 or 3 weeks protocol ,until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit.Anti-tumor efficacy is evaluated every 2/3 cycles (every 6 weeks) based on computed tomography (CT) or magnetic resonance imaging (MRI) results and their tumor markers, according to RECIST v1.1 criteria.
Inosine tablets were purchased from Tianjin Jinshi, dosage: 0.2g orally 3 times/day, PD-1/PD-L1 inhibitors, chemotherapy and targeted combination therapy regimens were developed by the investigators according to the NCCN guidelines and CSCO guidelines and the patient's condition and its staging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inosine group | Experimental | Drug: Inosine 0.2g orally 3 times/dayParticipants will receive inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting,every 2 or 3 weeks, until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit |
| non-inosine group | Active comparator | Drug: PD-1/PD-L1 inhibitor ,chemotherapy/targetingParticipants will receive PD-1/PD-L1 inhibitor ± chemotherapy/targeting, every 2 or 3 weeks .until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically confirmed unresectable locally advanced, recurrent or metastatic solid tumors
- Age 18 years old - 75 years old
- ECOG score of ≤ 2
- Time to end of palliative treatment for localized lesions (non-target lesions) was >3 weeks from randomization start time, At least one measurable lesion or assessable lesion according to RECIST v1.1
- Can provide archived pathological tissues or fresh pathological tissues for PD-L1, MMR/MSI, TMB testing within 6 months from the signing of the informed consent for screening and can obtain the test results
Key exclusion criteria (17 listed)
- Signs of active bleeding or perforation
- History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection, Crohn's disease, ulcerative colitis
- Hepatic metastatic focal load of approximately 50% or more of the entire liver volume
- Antibiotic was used within 2 weeks before study treatment
- Received systemic antitumor therapy with herbs or immunomodulatory drugs (including thymidine, interferon, interleukin, etc.) within 2 weeks before the first dose.
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 |
|---|---|---|
| Inosine 0.2g orally 3 times/dayAlso: Camrelizumab for injection, Sintilimab injection, Penpulimab injection, Tislelizumab injectioninosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, | Drug | inosine group |
| PD-1/PD-L1 inhibitor ,chemotherapy/targetingAlso: Camrelizumab for injection, Sintilimab injection, Penpulimab injection, Tislelizumab injectionPD-1/PD-L1 inhibitor ± chemotherapy/targeting | Drug | non-inosine group |
Primary outcome
overall survival (OS)
Time frame: 36 months
Time from randomization grouping to death from any cause
progression-free survival (PFS)
Time frame: 36 months
Time from randomization grouping to the first recorded disease progression or death from any cause
2 secondary outcomes
objective remission rate(ORR) [ Time Frame: Up to 36 months ]
Time frame: 36 months
disease control rate (DCR)
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 39267574Zhao H, Zhang W, Lu Y, Dong Y, He Z, Zhen H, Li Q. Inosine enhances the efficacy of immune-checkpoint inhibitors in advanced solid tumors: A randomized, controlled, Phase 2 study. Cancer Med. 2024 Sep;13(17):e70143. doi: 10.1002/cam4.70143.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inosine 0.2g orally 3 times/day and PD-1/PD-L1 inhibitor ,chemotherapy/targeting in people with Advanced Solid Tumor, run by Beijing Friendship Hospital 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 12 Apr 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: 36 months). The study lists 2 primary outcomes in all. 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 NCT05809336, 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 12 Apr 2023.