Biliary Tract NeoplasmsPhase 3KN035-BTCNCT03478488
Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC
A Phase 3 study testing KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin in people with Biliary Tract Neoplasms, run by 3D Medicines (Sichuan) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms
- What is being tested?
- KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2018to 10 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years and older;
- Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
- Previously untreated with systemic therapy; Subjects who developed recurrent disease >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
- Liver function Child-Pugh A or B;
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- Life expectancy of at least 12 weeks;
- At least one measurable lesion per RECIST 1.1;
- Adequate organ function
Who cannot join
- Specific anti-tumor treatment prior to 4 weeks;
- more than 50% liver metastasis ;
- Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
- History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
- Women who are pregnant or in the period of lactation;
- Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;
Trial locations and contacts
1 site in 1 country.
China1 site
The Chinese people's liberation army (PLA) 81hospital
Nanjing, Jiangsu, 210002
About this study
Official title: Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer.
The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
- Conditions
- Biliary Tract Neoplasms
- Being tested
- KN035 plus Gemcitabine & oxaliplatin, Gemcitabine & oxaliplatin
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN035 plus Gemcitabine & oxaliplatinDrug
Also called Experimental
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Gemcitabine & oxaliplatinDrug
Also called Active Comparator
The standard of care for the patients with unresectable/metastatic biliary tract cancer
| Study group | Role | What they receive |
|---|---|---|
| KN035 | Experimental | KN035 plus Gemcitabine \& oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle.
Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles. Receives: Drug: KN035 plus Gemcitabine & oxaliplatin |
| Gemcitabine & oxaliplatin | Active comparator | Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles. Receives: Drug: Gemcitabine & oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
was defined as the time from randomization to death due to any cause.
Measured: Observed by 12 weeks after progressive disease or end of treatment
Secondary outcomes (5)
Progression Free Survival (PFS)
was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent Review Committee (BIRC) review.
Measured: Observed by 6 weeks
Objective response rate (ORR)
was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on BIRC evaluation.
Measured: Observed by 6 weeks
Disease control rate (DCR)
was defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response or stable disease and was assessed using RECIST 1.1 based on BIRC evaluation
Measured: Observed by 6 weeks
Duration of Response (DOR)
was defined as the time from the first met for complete response/partial response (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study)
Measured: Observed by 6 weeks
Time to progression (TTP)
was defined as the time from randomization to the first date that progressive disease was objectively documented
Measured: Observed by 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start16 Apr 2018
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract NeoplasmsStudies 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
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, Principal investigator, The Chinese people's liberation army (PLA) 81 hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478488
- Sponsor's protocol ID
- KN035-CN-005
- Acronym
- KN035-BTC
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study
- ClinicalTrials.gov ID
- NCT03478488
- Acronym / sponsor ID
- KN035-BTC / KN035-CN-005
- Conditions
- Biliary Tract Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 27 Mar 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.
This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer.
The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN035 | Experimental | Drug: KN035 plus Gemcitabine & oxaliplatinKN035 plus Gemcitabine \& oxaliplatin KN035 2.5 mg/Kg, administered as subcutaneous injection, weekly of each 21-day cycle. Gemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles. |
| Gemcitabine & oxaliplatin | Active comparator | Drug: Gemcitabine & oxaliplatinGemcitabine 1000 mg/m^2, IV infusion on Day 1 and Day 8, and oxaliplatin 85 mg/m^2, IV infusion on Day 1 of each 21-day cycle for no more than 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eighteen years and older;
- Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma;
- Previously untreated with systemic therapy; Subjects who developed recurrent disease >6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible.
- Liver function Child-Pugh A or B;
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
Key exclusion criteria (6 listed)
- Specific anti-tumor treatment prior to 4 weeks;
- more than 50% liver metastasis ;
- Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc;
- History of severe hypersensitivity reaction to any monoclonal antibody or chemistry;
- Women who are pregnant or in the period of lactation;
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 |
|---|---|---|
| KN035 plus Gemcitabine & oxaliplatinAlso: ExperimentalKN035 a programmed death ligand immune check inhibitor Per Investigator decision | Drug | KN035 |
| Gemcitabine & oxaliplatinAlso: Active ComparatorThe standard of care for the patients with unresectable/metastatic biliary tract cancer | Drug | Gemcitabine & oxaliplatin |
Primary outcome
Overall Survival (OS)
Time frame: Observed by 12 weeks after progressive disease or end of treatment
was defined as the time from randomization to death due to any cause.
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: Observed by 6 weeks
Objective response rate (ORR)
Time frame: Observed by 6 weeks
Disease control rate (DCR)
Time frame: Observed by 6 weeks
Duration of Response (DOR)
Time frame: Observed by 6 weeks
Time to progression (TTP)
Time frame: Observed by 6 weeks
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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Biliary Tract Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
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.
Shukui Qin principal investigator
The Chinese people's liberation army (PLA) 81 hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin in people with Biliary Tract Neoplasms, run by 3D Medicines (Sichuan) Co., Ltd. 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 8 inclusion and 6 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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: Observed by 12 weeks after progressive disease or end of treatment). 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 23 Sep 2026.