CancerPhase 3NCT02889692
Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma
A Phase 3 study testing YiQiFang, YangYinFang and YiQiYangYinFang in people with Cancer, run by Shanghai University of Traditional Chinese Medicine.
Trial summary
The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- YiQiFang, YangYinFang and YiQiYangYinFang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to 1 Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;
- The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
- Age ≥18 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
- Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
- Planning for targeted maintenance.
- Informed consent from the patient.
Who cannot join
- The efficacy evaluation of the first-line therapy is progressive disease(PD);
- Patient with other malignant tumor except NSCLC 5 years previous to study entry;
- Patient has already received chemotherapy or other anticancer treatment;
- Estimated life expectancy less than 12 weeks;
- Brain metastasis (controlled brain metastasis and steroid free need is excluded);
- History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
About this study
Official title: Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial
The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.
Read the detailed description
Maintenance therapy refers to systemic therapy that may be given for patients with advanced NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates for maintenance therapy if they have responded to their previous treatment or have stable disease and their tumors have not progressed. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced pulmonary adenocarcinoma. Targeted therapy maintenance can be partly extend patient's TTP, but the toxicity and the side effects of targeted therapy will decrease QOL. Besides, high cost of targeted therapy will cause greater economic pressure on patients.The investigators' preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve QOL, but high-level evidences are needed.
The investigators perform a multicenter, randomized, double blind controlled, prospective study in advanced pulmonary adenocarcinoma patients with stage Ⅲ～Ⅳ. Advanced pulmonary adenocarcinoma patients after first-line chemotherapy will choose maintenance therapy according to the patient's wishes, including targeted therapy maintenance, chemotherapy maintenance and TCM maintenance therapy. Patients who choose targeted therapy maintenance are randomized over observational group (TCM granules plus targeted therapy maintenance),and control group (TCM placebo plus targeted therapy maintenance). The treatment should be continued until evidence of disease progression or unacceptable toxicity, and after that regular follow-up will be arranged. The primary efficacy assessments are: OS (overall survival); Secondary efficacy assessments are: (1) PFS (progression-free survival); (2) Objective response rate; (3) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0 scales; Lung Cancer Symptom Scale, LCSS); (4) other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with targeted therapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy maintenance. Therefore the study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
- Conditions
- Cancer
- Being tested
- YiQiFang, YangYinFang, YiQiYangYinFang, placebo granules, Erlotinib®
- Keywords
- lung cancer, traditional Chinese medicine, maintenance therapy, targeted therapy
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YiQiFangDrug
Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.
YangYinFangDrug
Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.
YiQiYangYinFangDrug
Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.
placebo granulesDrug
Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.
Erlotinib®Drug
Also called tarceva
"Erlotinib®","tarceva", 150 mg oral once a day until progression or unacceptable toxicity develops.
Gefitinib®Drug
Also called Iressa
"Gefitinib®","Iressa", 250 mg oral once a day until progression or unacceptable toxicity develops.
Icotinib®Drug
Also called Conmana
"Icotinib®","Conmana" 125 mg oral three times a day until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| TCM granules plus EGFR-TKIs | Experimental | TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity. Receives: Drug: YiQiFang; Drug: YangYinFang; Drug: YiQiYangYinFang; Drug: Erlotinib®; Drug: Gefitinib®; Drug: Icotinib® |
| Placebo granules plus EGFR-TKIs | Placebo comparator | Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity. Receives: Drug: placebo granules; Drug: Erlotinib®; Drug: Gefitinib®; Drug: Icotinib® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.
Measured: 2 months
Secondary outcomes (3)
Progression-free survival (PFS)
Time from start of the study treatment to date of objective tumour progression (excluding clinical deterioration without evidence of objective progression).
Measured: 2 months
Objective response rate (ORR)
The ORR (complete response (CR) plus partial response (PR)) was determined by the Response Evaluation Criteria In Solid Tumors (RECIST) (Eisenhauer et al, 2009) version 1.1.in Solid Tumors (RECIST1.1).
Measured: 2 months
Quality of life (QOL)
QOL is assessed using Functional Assessment of Cancer therapy-lung (FACT-L) questionnaire .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMar 2013
- Primary completion30 Dec 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Xu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Ling c, MD & PhD, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889692
- Sponsor's protocol ID
- LH127
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chinese Medicine Plus Targeted Therapy Maintenance Versus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma: A Randomized Double-blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02889692
- Acronym / sponsor ID
- LH127
- Conditions
- Cancer
- Keywords
- lung cancer, traditional Chinese medicine, maintenance therapy, targeted therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- Mar 2013
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
The investigators performed a randomized, double blind controlled, prospective study method on observation of Traditional Chinese Medicine (TCM) combined with targeted therapy maintenance to prolong the efficacy of long-term survival of advanced pulmonary adenocarcinoma patients. The investigators plan to involve 200 cases for observation in 3 years (100 cases for targeted therapy maintenance, 100 cases for targeted therapy maintenance plus TCM,), expecting that integrated TCM combined with targeted maintenance therapy has a better efficacy on prolonging progression-free survival time, overall survival, improving quality of life(QOL) of patients than that of targeted maintenance therapy.
Detailed description
Maintenance therapy refers to systemic therapy that may be given for patients with advanced NSCLC after 4 to 6 cycles of first-line chemotherapy. However, patients are only candidates for maintenance therapy if they have responded to their previous treatment or have stable disease and their tumors have not progressed. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFRTKIs) such as Iressa and Erlotinib have proved effective in first or second line therapy for advanced pulmonary adenocarcinoma. Targeted therapy maintenance can be partly extend patient's TTP, but the toxicity and the side effects of targeted therapy will decrease QOL. Besides, high cost of targeted therapy will cause greater economic pressure on patients.The investigators' preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival time and improve QOL, but high-level evidences are needed.
The investigators perform a multicenter, randomized, double blind controlled, prospective study in advanced pulmonary adenocarcinoma patients with stage Ⅲ～Ⅳ. Advanced pulmonary adenocarcinoma patients after first-line chemotherapy will choose maintenance therapy according to the patient's wishes, including targeted therapy maintenance, chemotherapy maintenance and TCM maintenance therapy. Patients who choose targeted therapy maintenance are randomized over observational group (TCM granules plus targeted therapy maintenance),and control group (TCM placebo plus targeted therapy maintenance). The treatment should be continued until evidence of disease progression or unacceptable toxicity, and after that regular follow-up will be arranged. The primary efficacy assessments are: OS (overall survival); Secondary efficacy assessments are: (1) PFS (progression-free survival); (2) Objective response rate; (3) QOL (Functional Assessment of Cancer therapy-lung, FACT-L4.0 scales; Lung Cancer Symptom Scale, LCSS); (4) other efficacy assessments are: 1) TCM symptoms changes; 2) Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with targeted therapy maintenance has a better efficacy on prolonging progression-free survival time, overall survival, improving QOL of patients than that of targeted therapy maintenance. Therefore the study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.
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 |
|---|---|---|
| TCM granules plus EGFR-TKIs | Experimental | Drug: YiQiFang, Drug: YangYinFang, Drug: YiQiYangYinFang, Drug: Erlotinib®, Drug: Gefitinib®, Drug: Icotinib®TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day，until progression or unacceptable toxicity. |
| Placebo granules plus EGFR-TKIs | Placebo comparator | Drug: placebo granules, Drug: Erlotinib®, Drug: Gefitinib®, Drug: Icotinib®Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;
- The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
- Age ≥18 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
Key exclusion criteria (8 listed)
- The efficacy evaluation of the first-line therapy is progressive disease(PD);
- Patient with other malignant tumor except NSCLC 5 years previous to study entry;
- Patient has already received chemotherapy or other anticancer treatment;
- Estimated life expectancy less than 12 weeks;
- Brain metastasis (controlled brain metastasis and steroid free need is excluded);
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 |
|---|---|---|
| YiQiFangPrescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable. | Drug | TCM granules plus EGFR-TKIs |
| YangYinFangPrescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable. | Drug | TCM granules plus EGFR-TKIs |
| YiQiYangYinFangPrescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable. | Drug | TCM granules plus EGFR-TKIs |
| placebo granulesOral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable. | Drug | Placebo granules plus EGFR-TKIs |
| Erlotinib®Also: tarceva"Erlotinib®","tarceva", 150 mg oral once a day until progression or unacceptable toxicity develops. | Drug | Placebo granules plus EGFR-TKIs, TCM granules plus EGFR-TKIs |
| Gefitinib®Also: Iressa"Gefitinib®","Iressa", 250 mg oral once a day until progression or unacceptable toxicity develops. | Drug | Placebo granules plus EGFR-TKIs, TCM granules plus EGFR-TKIs |
| Icotinib®Also: Conmana"Icotinib®","Conmana" 125 mg oral three times a day until progression or unacceptable toxicity develops. | Drug | Placebo granules plus EGFR-TKIs, TCM granules plus EGFR-TKIs |
Primary outcome
Overall survival (OS)
Time frame: 2 months
It referred to the interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 months
Objective response rate (ORR)
Time frame: 2 months
Quality of life (QOL)
Time frame: 2 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 11 Apr 2019.
- Individual participant dataSharing planned: Yes
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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.
Ling c, MD & PhD principal investigator
Longhua Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YiQiFang, YangYinFang and YiQiYangYinFang in people with Cancer, run by Shanghai University of Traditional Chinese Medicine.
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 8 inclusion and 8 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 11 Apr 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?
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: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2019.