Biliary Tract CancerPhase 2NCT07159217
Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer
A Phase 2 study testing Disitamab Vedotin, Lenvatinib and Pembrolizumab in people with Biliary Tract Cancer and Disitamab Vedotin, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This trial is a single-arm exploratory phase II clinical study initiated by the investigator. Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib
- What is being tested?
- Disitamab Vedotin, Lenvatinib and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 31 May 2028
- Phase
- Phase 2
- 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
- Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.
- Age ≥ 18 years and any gender.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
- At least one measurable lesion (according to RECIST 1.1).
- ECOG performance status score of 0-1.
- Child-Pugh score ≤ 7 .
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- HER2 expression confirmed by: Immunohistochemistry (IHC 2+ or 3+); or Fluorescence in situ hybridization (FISH) with HER2/CEP17 ratio ≥2.0; or Next-generation sequencing (NGS) showing HER2 amplification.
- No prior HER2-targeted therapy (including antibody-based agents, small-molecule TKIs, or antibody-drug conjugates) before randomization.
- Expected survival > 12 weeks.
- Adequate hematological and major organ function.
Who cannot join
- Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
- Pregnant women (positive pregnancy test before medication) or lactating women.
- Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
- History of other active malignancies within 5 years prior to screening.
- Presence of central nervous system metastasis and/or leptomeningeal metastasis.
- Unhealed severe wounds, active ulcers, or untreated fractures.
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- Administration of live vaccines within 30 days prior to randomization.
- Active autoimmune disease or history of autoimmune disease.
- Presence of clinically significant gastrointestinal disorders.
- Presence of clinically significant cardiovascular or cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing
Haitao Zhao, +86-10-69152830, zhaoht@pumch.cn
Haitao Zhao
About this study
Official title: A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer
This trial is a single-arm exploratory phase II clinical study initiated by the investigator.
Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.
- Being tested
- Disitamab Vedotin, Lenvatinib, Pembrolizumab, Toripalimab, Camrelizumab
- Keywords
- Biliary tract cancer, Disitamab vedotin, Lenvatinib, Immune checkpoint inhibitors
- 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.
Disitamab VedotinDrug
2.0 mg/kg administered intravenously every three weeks
LenvatinibDrug
≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily
PembrolizumabDrug
200 mg intravenously every three weeks
ToripalimabDrug
240 mg intravenously every three weeks
CamrelizumabDrug
200 mg intravenously every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Disitamab vedotin combined with lenvatinib and PD-1 inhibitor | Experimental | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab) Receives: Drug: Disitamab Vedotin; Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Toripalimab; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR, objective response rate
Measured: 12 months after the last subject is enrolled
Secondary outcomes (5)
PFS, progression free survival
Measured: 12 months after the last subject is enrolled
OS, overall survival
Measured: 12 months after the last subject is enrolled
DCR, disease control rate
Measured: 12 months after the last subject is enrolled
DoR, duration of response
Measured: 12 months after the last subject is enrolled
Adverse events (AE) and serious adverse events (SAE)
To evaluate safety, incidence and outcome of adverse events (AE), and serious adverse events (SAE)
Measured: 12 months after the last subject is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Aug 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (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 Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159217
- Sponsor's protocol ID
- K8721
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M. Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. Drug Deliv. 2022 Dec;29(1):1335-1344. doi: 10.1080/10717544.2022.2069883.
PubMed 35506447
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploratory Phase II Study of Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for the Treatment of HER2-positive Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07159217
- Acronym / sponsor ID
- K8721
- Keywords
- Biliary tract cancer, Disitamab vedotin, Lenvatinib, Immune checkpoint inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 8 Sep 2025 (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 trial is a single-arm exploratory phase II clinical study initiated by the investigator.
Subjects who met the research criteria were screened and enrolled to receive the treatment regimen of disitamab vedotin combined with lenvatinib and PD-1 inhibitor. During the treatment process, the researchers closely followed up, strictly evaluated the efficacy, assessed the efficacy and safety of the subjects after receiving the combined treatment, evaluated the subjects until progression occurred, and observed their objective response rate, progression-free survival, overall survival, disease control rate, duration of response, and safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disitamab vedotin combined with lenvatinib and PD-1 inhibitor | Experimental | Drug: Disitamab Vedotin, Drug: Lenvatinib, Drug: Pembrolizumab, Drug: Toripalimab, Drug: CamrelizumabDisitamab vedotin combined with lenvatinib and PD-1 inhibitor (Pembrolizumab or Toripalimab or Camrelizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants who voluntarily participate in this study, sign the written informed consent, and are able to comply with the protocol.
- Age ≥ 18 years and any gender.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).
- At least one measurable lesion (according to RECIST 1.1).
- ECOG performance status score of 0-1.
Key exclusion criteria (10 listed)
- Histological or cytological diagnosis of combined hepatocellular-cholangiocarcinoma (cHCC-CCA), mucinous adenocarcinoma, sarcoma, or neuroendocrine tumors.
- Pregnant women (positive pregnancy test before medication) or lactating women.
- Known allergy or intolerance to disitamab vedotin, lenvatinib, PD-1 inhibitors, or their excipients.
- History of other active malignancies within 5 years prior to screening.
- Presence of central nervous system metastasis and/or leptomeningeal metastasis.
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 |
|---|---|---|
| Disitamab Vedotin2.0 mg/kg administered intravenously every three weeks | Drug | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor |
| Lenvatinib≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily | Drug | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor |
| Pembrolizumab200 mg intravenously every three weeks | Drug | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor |
| Toripalimab240 mg intravenously every three weeks | Drug | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor |
| Camrelizumab200 mg intravenously every three weeks | Drug | Disitamab vedotin combined with lenvatinib and PD-1 inhibitor |
Primary outcome
ORR, objective response rate
Time frame: 12 months after the last subject is enrolled
5 secondary outcomes
PFS, progression free survival
Time frame: 12 months after the last subject is enrolled
OS, overall survival
Time frame: 12 months after the last subject is enrolled
DCR, disease control rate
Time frame: 12 months after the last subject is enrolled
DoR, duration of response
Time frame: 12 months after the last subject is enrolled
Adverse events (AE) and serious adverse events (SAE)
Time frame: 12 months after the last subject is enrolled
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 8 Sep 2025.
- Background: PubMed 35506447Shi F, Liu Y, Zhou X, Shen P, Xue R, Zhang M. Disitamab vedotin: a novel antibody-drug conjugates for cancer therapy. Drug Deliv. 2022 Dec;29(1):1335-1344. doi: 10.1080/10717544.2022.2069883.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin, Lenvatinib and Pembrolizumab in people with Biliary Tract Cancer and Disitamab Vedotin, run by Peking Union Medical College Hospital 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 10 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shuofeng Li (+86-10-69156042, shuofengli@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR, objective response rate (time frame: 12 months after the last subject is enrolled). 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 NCT07159217, 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 8 Sep 2025.