Biliary Tract Cancer (BTC)Phase 3NCT06622057
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
A Phase 3 study testing D07001-Softgel Capsules and Capecitabine in people with Biliary Tract Cancer (BTC), run by InnoPharmax Inc. at 5 sites in 2 countries.
Trial summary
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- D07001-Softgel Capsules and Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 9 Jun 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- Participant aged at least 18 years at the time of consent.
- Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
- Participant has measurable disease as assessed by central review by RECIST v1.1.
- Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on irinotecan + fluorouracil-based chemotherapy.
- Participants with tumors expressing the following biomarkers may be enrolled even if they have not previously received FOLFOX but have received appropriate targeted therapies until disease progression or intolerance: fibroblast growth factor receptors (FGFR) aberrations, microsatellite instability biomarker/deficient DNA mismatch repair, Tumor Mutation Burden-high, or mutations in isocitrate dehydrogenase, BRAF, HER2, NTRK, RET, or KRAS G12C.
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- Participant has ECOG PS of 0-2.
- Participant's life expectancy is ≥12 weeks.
- Participant has adequate bone marrow function, demonstrated by:
- Absolute neutrophil count ≥1500 cell/mm3.
- Platelet count ≥85,000 cells/mm3.
- Hemoglobin ≥9 g/dL.
- Participant has adequate liver function, demonstrated by:
- Aspartate transaminase and alanine transaminase ≤2.5 × upper limit of normal (ULN), or ≤5.0 × ULN in the case of liver lesions.
- Total bilirubin ≤1.5 × ULN.
- Albumin ≥3.0 g/dL.
- International normalized ratio <1.5.
- Participant has adequate renal function, demonstrated by creatinine clearance ≥ 45 mL/min calculated by Cockcroft-Gault formula or estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine equation.
- No clinically significant abnormalities in coagulation results.
- Participant is eligible to participate if not pregnant (as demonstrated by serum pregnancy testing at Screening), not breastfeeding, and at least 1 of the following conditions applies:
- Not of childbearing potential (CBP). Participants of non-childbearing potential are defined as those with functioning ovaries with a documented history of tubal ligation or hysterectomy or who are postmenopausal, as defined by 12 months of spontaneous amenorrhea with an appropriate clinical profile, e.g., age appropriate, >45 years, in the absence of hormone replacement therapy. If necessary, a blood sample for follicle stimulating hormone will be obtained to confirm postmenopausal status.
- A participant of CBP who is sexually active with a partner who could impregnate them agrees to use a highly effective form of contraception during the study and for at least 6 months after the EOS intervention.
- Participants with partners of childbearing potential whom they could impregnate must agree to use contraception during the study and for 3 months after the EOS intervention.
- Participants who are able to donate sperm must refrain from sperm donation during the study and for 3 months after the EOS intervention.
- Participant is willing to comply with the protocol-required visit schedule and visit requirements.
- More than 14 days have elapsed between the participant completing a prior line of chemotherapy or targeted therapy, and enrollment. More than 28 days have elapsed between the participant receiving concurrent radiotherapy (CCRT) and enrollment
Who cannot join
- Participant has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.
- Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.
- Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
- Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
- Participant is currently receiving flucytosine treatment.
- Participant has residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted).
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- Participant has any gastrointestinal disorder or prior gastrointestinal surgery that would significantly impede absorption of an oral agent, such as gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome.
- Participant has known brain or leptomeningeal metastases.
- Participant had major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days.
- Participant has any active disease or condition that would not permit compliance with the protocol.
- Participant has clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, New York Heart Association Grade 2 or greater), or uncontrolled serious cardiac arrhythmia.
- Participant has documented cerebrovascular disease.
- Participant has a seizure disorder not controlled with medication (based on Investigator's decision).
- Participant has received an investigational agent within 28 days of enrollment.
- Participant has an uncontrolled active viral, bacterial, or systemic fungal infection.
- Participants with positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (anti-HCV) and detectable hepatitis B virus (HBV) DNA ≥2000 copies/mL or hepatitis C virus (HCV) RNA above the institutional lower limit of quantification are excluded. Participants with resolved HBV infection (negative HBsAg and positive hepatitis B core antibody [anti-HBc]) are eligible if HBV DNA is <2000 copies/mL. Participants with positive anti-HCV antibody must have completed curative antiviral therapy and have undetectable HCV RNA by PCR to be eligible.
- Has positive human immunodeficiency virus antibody.
- Participant has received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks before Screening.
- Participant has a history of drug or alcohol abuse within the year before signing the informed consent form.
- Participant has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in or compliance with the clinical trial.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
Amit Mahipal, +1-216-844-3951, Amit.Mahipal@UHhospitals.org
Amit Mahipal
- Not yet recruiting
Texas Oncology
Dallas, Texas, 75246
Christine Terraciano, Christine.Terraciano@usoncology.com
Andrew Paulson
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Yvonne Enriquez Nunez, +1-305-674-2625, Yvonne.Enriquez@msmc.com
Mike Cusnir
- Recruiting
The University of Arizona Cancer Center
Tucson, Arizona, 85724
Prisca Zimmerman, +1-520-626-8286, priscaz@arizona.edu
Rachna Shroff, MD
Taiwan1 site, 1 recruiting
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Li-Tzong Chen, M.D., 886-73121101
Li-Tzong Chen
About this study
Official title: Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.
Read the detailed description
This is a Phase III, randomized, double-blind, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of D07001-softgel capsules + capecitabine tablets in participants with advanced BTC after failure on an intravenous gemcitabine and cisplatin-based, and also failed on or refused FOLFOX or failed on irinotecan and fluorouracil regimen. Approximately 195 participants (approximately 65 per treatment arm) will be randomized 1:1:1 to one of the following treatment arms:
- Oral D07001 softgel capsules, 100 mg/day + capecitabine tablets (1000 mg/m2 twice daily [bid])
- Oral D07001 softgel capsules, 60 mg/day + capecitabine tablets (1000 mg/m2 bid)
- Oral placebo softgel capsules + capecitabine tablets (1000 mg/m2 bid) A formal interim futility analysis will be conducted when approximately 80 participants have either experienced disease progression or death. Study participants will continue study treatment until unacceptable toxicity, disease progression, death, withdrawal of consent to treatment, or completing 12 treatment cycles, whichever comes first. The EOT Visit will occur following unacceptable toxicity, disease progression, completing 12 treatment cycles or withdrawal of consent to treatment. Follow-up Period/Visits over phone call will be conducted for participants on 30 ± 3 days, every month; and at 365 ± 3 days following the EOT Visit.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- D07001-Softgel Capsules, Placebo, Capecitabine
- Keywords
- BTC, cholangiocarcinoma, Biliary Tract Cancer, third-line
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D07001-Softgel CapsulesDrug
D07001-softgel capsule is an oral gemcitabine.
PlaceboDrug
Placebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs)
CapecitabineCombination product
Capecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent.
| Study group | Role | What they receive |
|---|---|---|
| D07001-Softgel Capsules 60 mg + Capecitabine | Experimental | * D07001-softgel capsules, 60 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle)
* Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. Receives: Drug: D07001-Softgel Capsules; Combination Product: Capecitabine |
| D07001-Softgel Capsules 100 mg + Capecitabine | Experimental | * D07001-softgel capsules, 100 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle)
* Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. Receives: Drug: D07001-Softgel Capsules; Combination Product: Capecitabine |
| Placebo + Capecitabine | Placebo comparator | * Placebo, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle)
* Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. Receives: Drug: Placebo; Combination Product: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To assess the over survival (OS) of 2 doses of D07001-softgel capsules + capecitabine compared with placebo + capecitabine
Measured: From date of randomization until the date of death, assessed up to 2 years
Secondary outcomes (4)
progression-free survival (PFS)
To assess the progression-free survival (PFS) of D07001-softgel capsules + capecitabine compared with placebo + capecitabine
Measured: From randomization to death or progression disease, assessed up to 2 years
6-month survival rate
To assess the 6-month OS of D07001-softgel capsules + capecitabine compared with placebo + capecitabine
Measured: Assessed as the time at 6 month timepoint from randomization
overall response rate (ORR)
To assess the overall response rate (ORR) of D07001-softgel capsules + capecitabine
Measured: From treatment starting until end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).
Quality of life (QOL) will be assessed using the EORTC questionnaires
To access healthy related quality of life of cancer patients participating in clinical trial.
Measured: Assessed as the time from randomization to end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start9 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoPharmax Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Criss Cheng, Study director, InnoPharmax Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622057
- Sponsor's protocol ID
- Inno-GO-07
- Status last verified
- Nov 2026
- First submitted
- 23 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens
- ClinicalTrials.gov ID
- NCT06622057
- Acronym / sponsor ID
- Inno-GO-07
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- BTC, cholangiocarcinoma, Biliary Tract Cancer, third-line
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- InnoPharmax Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Oct 2024 (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.
The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.
Detailed description
This is a Phase III, randomized, double-blind, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of D07001-softgel capsules + capecitabine tablets in participants with advanced BTC after failure on an intravenous gemcitabine and cisplatin-based, and also failed on or refused FOLFOX or failed on irinotecan and fluorouracil regimen. Approximately 195 participants (approximately 65 per treatment arm) will be randomized 1:1:1 to one of the following treatment arms:
- Oral D07001 softgel capsules, 100 mg/day + capecitabine tablets (1000 mg/m2 twice daily [bid])
- Oral D07001 softgel capsules, 60 mg/day + capecitabine tablets (1000 mg/m2 bid)
- Oral placebo softgel capsules + capecitabine tablets (1000 mg/m2 bid) A formal interim futility analysis will be conducted when approximately 80 participants have either experienced disease progression or death. Study participants will continue study treatment until unacceptable toxicity, disease progression, death, withdrawal of consent to treatment, or completing 12 treatment cycles, whichever comes first. The EOT Visit will occur following unacceptable toxicity, disease progression, completing 12 treatment cycles or withdrawal of consent to treatment. Follow-up Period/Visits over phone call will be conducted for participants on 30 ± 3 days, every month; and at 365 ± 3 days following the EOT Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D07001-Softgel Capsules 60 mg + Capecitabine | Experimental | Drug: D07001-Softgel Capsules, Combination Product: Capecitabine* D07001-softgel capsules, 60 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. |
| D07001-Softgel Capsules 100 mg + Capecitabine | Experimental | Drug: D07001-Softgel Capsules, Combination Product: Capecitabine* D07001-softgel capsules, 100 mg/day, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. |
| Placebo + Capecitabine | Placebo comparator | Drug: Placebo, Combination Product: Capecitabine* Placebo, orally 3 times per week before lunch (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle) * Capecitabine tablets (1000 mg/m2 bid) for 14 days (on Days 1 through 14 of a 21 day cycle) followed by a 7-day rest period. Capecitabine will be taken after breakfast and after dinner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements.
- Participant aged at least 18 years at the time of consent.
- Participant has histopathological or cytologic diagnosis of unresectable, locally advanced or metastatic BTC (cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
- Participant has measurable disease as assessed by central review by RECIST v1.1.
- Participant must have failed on a gemcitabine + cisplatin-based chemotherapy, regardless of whether an immune checkpoint inhibitor, such as durvalumab or pembrolizumab, or S-1 (tegafur, gimeracil, and oteracil potassium), was also administered. Oxaliplatin or carboplatin may be substituted for cisplatin when renal or auditory function is of concern. Participants also have failed (disease progression or intolerance) on, or refused FOLFOX chemotherapy, including modified FOLFOX variants, or failed on irinotecan + fluorouracil-based chemotherapy.
Key exclusion criteria (20 listed)
- Participant has a diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent.
- Participant discontinued prior gemcitabine due to pulmonary or hepatic toxicity or hemolytic uremic syndrome, hypersensitivity, allergic reaction, or intolerance.
- Participant had a prior unanticipated severe reaction to capecitabine or metabolites or to fluoropyrimidine therapy.
- Participant received treatment with brivudine, sorivudine, or its chemically related analogs ≤28 days prior to the date of enrollment.
- Participant is currently receiving flucytosine treatment.
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 |
|---|---|---|
| D07001-Softgel CapsulesD07001-softgel capsule is an oral gemcitabine. | Drug | D07001-Softgel Capsules 100 mg + Capecitabine, D07001-Softgel Capsules 60 mg + Capecitabine |
| PlaceboPlacebo has the same excipient with D07001-softgel but without active pharmaceutical ingredients (APIs) | Drug | Placebo + Capecitabine |
| CapecitabineCapecitabine, a fluoropyrimidine carbamate derivative, is an oral tumor activator and selective cytotoxic agent. | Combination product | D07001-Softgel Capsules 100 mg + Capecitabine, D07001-Softgel Capsules 60 mg + Capecitabine, Placebo + Capecitabine |
Primary outcome
Overall Survival (OS)
Time frame: From date of randomization until the date of death, assessed up to 2 years
To assess the over survival (OS) of 2 doses of D07001-softgel capsules + capecitabine compared with placebo + capecitabine
4 secondary outcomes
progression-free survival (PFS)
Time frame: From randomization to death or progression disease, assessed up to 2 years
6-month survival rate
Time frame: Assessed as the time at 6 month timepoint from randomization
overall response rate (ORR)
Time frame: From treatment starting until end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).
Quality of life (QOL) will be assessed using the EORTC questionnaires
Time frame: Assessed as the time from randomization to end of treatment(EOT), assessed up to complete 12 treatment cycles (each cycle is 21 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Criss Cheng study director
InnoPharmax Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D07001-Softgel Capsules and Capecitabine in people with Biliary Tract Cancer (BTC), run by InnoPharmax Inc. at 5 sites in 2 countries.
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 26 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Taiwan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuyuan Lin (886-287977607 ext. 211, yuan.lin@innopharmax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From date of randomization until the date of death, assessed up to 2 years). 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 4 Nov 2026.