A Phase 3 interventional study of KN035 plus Gemcitabine & oxaliplatin and Gemcitabine & oxaliplatin in Biliary Tract Neoplasms, sponsored by 3D Medicines (Sichuan) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by 3D Medicines (Sichuan) Co., Ltd. · Phase 3, Interventional, and Treatment
Among 49 studies testing gemcitabine in Biliary Tract Neoplasms — 9 open to participants now, 13 under way, 2 of them phase 3. Gemcitabine · Biliary Tract Neoplasms.
Among the 49 studies testing gemcitabine in Biliary Tract Neoplasms, this one is the 2nd largest by enrollment, is one of 2 that started in 2018, is one of 3 in phase 3, and was the 33rd registered.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
Browse Biliary Tract Neoplasms studies →9 of the 49 studies testing gemcitabine in Biliary Tract Neoplasms are open now, in 5 countries. Recruiting first, the newest first:
Peking University · Sites in China
Ages 18–80
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Sites in China
Ages 18–75
Jinbo Yue · Sites in China
Ages 18–75
University of Maryland, Baltimore · Sites in United States
Ages 21+
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd · Sites in China
Ages 18–75
By country, each count listing its studies:
Gemcitabine: first FDA approval 1996 (GEMZAR). What it is approved for, and how studies give it, is on its page →
Of the 140 Biliary Tract Neoplasms studies recruiting now, 80 (57%) set no upper age limit and 37 (26%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
49 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 35 · Phase 3 4
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 472 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Median enrollment 44 across the 49 interventional studies. Of the 31 that completed or were terminated, 11 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 49 have an industry lead sponsor. The 10 most frequent:
3D Medicines (Sichuan) Co., Ltd. is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
3D Medicines (Sichuan) Co., Ltd. has 2 studies filed under Biliary Tract Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies testing gemcitabine in Biliary Tract Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02632305AHS Cancer Control AlbertaA Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer | 2026-12 |
| NCT07831993The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolSintilimab Plus NALIRIFOX or Gemcitabine-Cisplatin as First-Line Treatment for Metastatic Biliary Tract Cancer | 2027-06-30 |
| NCT07030140Jinbo YuePhase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma | 2027-07-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 49 studies testing gemcitabine in Biliary Tract Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: KN035 plus Gemcitabine & oxaliplatin
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.
Drug: Gemcitabine & oxaliplatin
Drug pages: Envafolimab · Gemcitabine · Oxaliplatin
KN035 a programmed death ligand immune check inhibitor Per Investigator decision
Also known as: Experimental
Drug pages: Gemcitabine · Oxaliplatin
The standard of care for the patients with unresectable/metastatic biliary tract cancer
Also known as: Active Comparator
Overall Survival (OS)
was defined as the time from randomization to death due to any cause.
Time frame: Observed by 12 weeks after progressive disease or end of treatment
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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Observed by 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Sep 2024, 76 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Envafolimab · Gemcitabine · Oxaliplatin
3D Medicines (Sichuan) Co., Ltd.