Probiotics Plus ChemotherapyPhase 3NCT03642548
Probiotics Combined With Chemotherapy for Patients With Advanced NSCLC
A Phase 3 study testing bifico in people with Probiotics Plus Chemotherapy, run by Shanghai 10th People's Hospital.
Trial summary
Based on the theory of intestinal lung axis, the effect of new therapy on patients with advanced NSCLC was observed by adjusting the intestinal micro-ecology and combining existing platinum-based doublet chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Probiotics Plus Chemotherapy
- What is being tested?
- bifico
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2019to 1 Mar 2024
- Phase
- Phase 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
- Patients have voluntarily to join the study and give written informed consent for the study.
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC).
- A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology).
- Received platinum-based doublet chemotherapy for first-line treatment.
- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- Patients did not receive systemic anti-cancer therapy previously, including traditional Chinese medicine.
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- Able to comply with study and follow-up procedures.
- Aged 18 to 75 years, ECOG PS: 0~1, estimated survival duration more than 3 months.
- Major organ function (1) For regular test results (no blood transfusion within 14 days): Hemoglobin（HB）≥90g/L; Absolute neutrophils count（ANC）≥1.5×10^9/L; Blood platelets（PLT）≥80×10^9/L; (2) Biochemical tests results defined as follows: Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN); Alanine aminotransferase（ALT）and aspartate amniotransferase AST≤2.5ULNliver metastases if anyALT和AST≤5ULN; Creatinine (Cr)≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min; (3) Patients voluntarily joined the study, signed informed consent, and good compliance.
Who cannot join
- Small cell lung cancer (including lung cancer mixed with small cell carcinoma and non-small cell carcinoma).
- Previously received anti-tumor treatment of any other organs, including radiotherapy, chemotherapy, immunotherapy and Chinese medicine treatment (except for previous radical treatment and no recurrence (treatment of malignant tumor with metastasis time ≥ 5 years).
- having a variety of factors affecting oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
- Patients with any severe and/or uncontrolled diseases, such as:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within months prior to randomization, severe uncontrolled arrhythmia; active or uncontrolled serious infections; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; Active tuberculosis, etc.; uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; Long-term unhealed wounds or fractures.
- Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder.
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- Participated in other clinical trials within four weeks.
- A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- It is known that there are severe allergic reactions (≥3 grade) to the active ingredients and or any excipients of other test drugs such as pemetrexed, gemcitabine, carboplatin, cisplatin.
- Use of immunosuppressive drugs within 4 weeks prior to enrollment, excluding nasal glucocorticoids or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids.
- known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituititis, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or Childhood asthma has been completely relieved, and patients who do not need any intervention after adulthood can be enrolled; patients with well-controlled insulin type I can also be enrolled).
- Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known.
- The history of non-infectious pneumonia requiring glucocorticoid therapy or the current presence of interstitial lung disease in the first year prior to enrollment.
- Accompanied by other malignant tumors (except for radical treatment, such as cervical carcinoma in situ, non-melanoma skin cancer, etc.); According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Multicenter Double-blind Randomized Clinical Trial of Probiotics Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
Based on the theory of intestinal lung axis, the effect of new therapy on patients with advanced NSCLC was observed by adjusting the intestinal micro-ecology and combining existing platinum-based doublet chemotherapy.
Read the detailed description
OBJECTIVES:
Primary outcomes To compare progression free survival (PFS) and objective response rate (ORR) in patients with stage IIIB or IV non-small cell lung cancer receiving Bifico versus placebo plus platinum-based doublet chemotherapy for first-line treatment.
Secondary outcomes To compare overall survival (OS) between the two arms； To evaluate the nature, severity, and frequency of toxicities between arms； To correlate the blood markers and fecal microbiome (at diagnosis) with outcomes and response.
OUTLINE:
This is a randomized, double-blind, placebo-controlled clinical trial. Patients are stratified according to center, performance status (0 or 1), tobacco use (never vs past or present), weight loss (< 5% vs ≥ 5% or unknown). Patients are randomized to 1 of 2 treatment arms.
BIFICO Group: Patients receive Bifico (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Placebo Group: Patients receive placebo (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Blood, tissue and fecal samples are collected and examined for biomarkers, gene mutations and fecal microbiome, and may be banked for future studies.
- Conditions
- Probiotics Plus Chemotherapy
- Being tested
- bifico, placebo
- Keywords
- NSCLC, Bifico, gut-lung axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bificoDrug
Patients in BIFICO group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Bifico.
placeboDrug
Patients in control group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Placebo.
| Study group | Role | What they receive |
|---|---|---|
| BIFICO Group | Experimental | The intervention group patients receive platinum-based doublet chemotherapy plus BIFICO (Dose: 420mg, 3 times a day, p.o) Receives: Drug: bifico |
| Control Gruop | Placebo comparator | The control group patients receive platinum-based doublet chemotherapy plus Placebo (Dose: 420mg, 3 times a day, p.o) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Measured: 14 months
Progression Free Survival (PFS)
progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
Measured: 6 months
Secondary outcomes (2)
Overall Survival (OS)
Randomization to Date of Death from Any Cause.
Measured: 5 years
Number of Participants With Toxicity
Incidence of Toxicities Measured by NCI CTCAE Version 4.0
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Feb 2019 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (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 Probiotics Plus ChemotherapyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Li, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642548
- Sponsor's protocol ID
- PCCAN
- Status last verified
- Feb 2019
- First submitted
- 16 Aug 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xia Q, Chen G, Ren Y, Zheng T, Shen C, Li M, Chen X, Zhai H, Li Z, Xu J, Gu A, Jin M, Fan L. Investigating efficacy of "microbiota modulation of the gut-lung Axis" combined with chemotherapy in patients with advanced NSCLC: study protocol for a multicenter, prospective, double blind, placebo controlled, randomized trial. BMC Cancer. 2021 Jun 22;21(1):721. doi: 10.1186/s12885-021-08448-6.
PubMed 34157996
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Double-blind Randomized Clinical Trial of Probiotics Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03642548
- Acronym / sponsor ID
- PCCAN
- Conditions
- Probiotics Plus Chemotherapy
- Keywords
- NSCLC, Bifico, gut-lung axis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai Chest Hospital
- Study start
- 21 Feb 2019 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Aug 2018 (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.
Based on the theory of intestinal lung axis, the effect of new therapy on patients with advanced NSCLC was observed by adjusting the intestinal micro-ecology and combining existing platinum-based doublet chemotherapy.
Detailed description
OBJECTIVES:
Primary outcomes To compare progression free survival (PFS) and objective response rate (ORR) in patients with stage IIIB or IV non-small cell lung cancer receiving Bifico versus placebo plus platinum-based doublet chemotherapy for first-line treatment.
Secondary outcomes To compare overall survival (OS) between the two arms； To evaluate the nature, severity, and frequency of toxicities between arms； To correlate the blood markers and fecal microbiome (at diagnosis) with outcomes and response.
OUTLINE:
This is a randomized, double-blind, placebo-controlled clinical trial. Patients are stratified according to center, performance status (0 or 1), tobacco use (never vs past or present), weight loss (< 5% vs ≥ 5% or unknown). Patients are randomized to 1 of 2 treatment arms.
BIFICO Group: Patients receive Bifico (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Placebo Group: Patients receive placebo (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Blood, tissue and fecal samples are collected and examined for biomarkers, gene mutations and fecal microbiome, and may be banked for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIFICO Group | Experimental | Drug: bificoThe intervention group patients receive platinum-based doublet chemotherapy plus BIFICO (Dose: 420mg, 3 times a day, p.o) |
| Control Gruop | Placebo comparator | Drug: placeboThe control group patients receive platinum-based doublet chemotherapy plus Placebo (Dose: 420mg, 3 times a day, p.o) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients have voluntarily to join the study and give written informed consent for the study.
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC).
- A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology).
- Received platinum-based doublet chemotherapy for first-line treatment.
- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
Key exclusion criteria (14 listed)
- Small cell lung cancer (including lung cancer mixed with small cell carcinoma and non-small cell carcinoma).
- Previously received anti-tumor treatment of any other organs, including radiotherapy, chemotherapy, immunotherapy and Chinese medicine treatment (except for previous radical treatment and no recurrence (treatment of malignant tumor with metastasis time ≥ 5 years).
- having a variety of factors affecting oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
- Patients with any severe and/or uncontrolled diseases, such as:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within months prior to randomization, severe uncontrolled arrhythmia; active or uncontrolled serious infections; liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; Active tuberculosis, etc.; uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; Long-term unhealed wounds or fractures.
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 |
|---|---|---|
| bificoPatients in BIFICO group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Bifico. | Drug | BIFICO Group |
| placeboPatients in control group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Placebo. | Drug | Control Gruop |
Primary outcome
Objective Response Rate (ORR)
Time frame: 14 months
Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Progression Free Survival (PFS)
Time frame: 6 months
progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
2 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Number of Participants With Toxicity
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 34157996Xia Q, Chen G, Ren Y, Zheng T, Shen C, Li M, Chen X, Zhai H, Li Z, Xu J, Gu A, Jin M, Fan L. Investigating efficacy of "microbiota modulation of the gut-lung Axis" combined with chemotherapy in patients with advanced NSCLC: study protocol for a multicenter, prospective, double blind, placebo controlled, randomized trial. BMC Cancer. 2021 Jun 22;21(1):721. doi: 10.1186/s12885-021-08448-6.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bifico in people with Probiotics Plus Chemotherapy, run by Shanghai 10th People's Hospital.
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 14 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lihong Fan, Doctor (+86 18001763288, fanlih@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 14 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 NCT03642548, 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 25 Feb 2019.