AzTrials
AzTrials

Biliary Tract Cancers (BTC)Phase 2DVDMSNCT07398339

Cosiporfin Sodium for Injection Photodynamic Therapy

A Phase 2 study testing Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection and Cisplatin for injection in people with Biliary Tract Cancers (BTC), run by Shanghai Guangsheng Biopharmaceutical Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancers (BTC)
What is being tested?
Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection and Cisplatin for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
31 Mar 2026to 31 Mar 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

  • Subjects must meet all of the following inclusion criteria to be enrolled in this study:
  • All subjects or their legal representatives must voluntarily sign an ethics committee-approved informed consent form in writing prior to initiating any screening procedures;
  • Age ≥ 18 years, no gender restrictions;
  • Patients with histologically or cytologically confirmed, locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery;
  • No prior systemic therapy during the recurrent or metastatic stage;
  • Presence of obstructive lesions in the extrahepatic bile ducts, with at least one measurable lesion outside the bile ducts according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
Show all 16Show fewer
  • Subjects with an ECOG performance status score of 0 or 1 (see Appendix 3 for details);
  • Subjects with an expected survival of ≥3 months;
  • Subjects with adequate organ and bone marrow function meeting the following laboratory criteria:
  • Bone marrow function: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/mm³) ; platelets ≥100 × 10⁹/L (1 × 10⁵/mm³); hemoglobin ≥9.0 g/dL (no treatment for bone marrow suppression, such as GCS-F, EPO, or blood transfusion, within 14 days prior to screening laboratory tests);
  • Renal Function: Creatinine clearance (Ccr) ≥50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 4);
  • Coagulation Function: International Normalized Ratio (INR) ≤1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN;
  • Echocardiogram: Left ventricular ejection fraction (LVEF) ≥50%;
  • 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) <470 msec (Appendix 4);
  • Recovered from all prior treatments with toxicities resolved to Grade 1 or below;
  • Female subjects of childbearing potential and all male subjects must agree to use highly effective contraception during the trial and for 6 months after the last dose of sodium porphyrin. contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptives, subcutaneous implant, etc.), and women of childbearing potential must have a negative pregnancy test result within ≤7 days prior to study drug administration.

Who cannot join

  • Subjects meeting any of the following criteria are ineligible for enrollment:
  • Patients with ampullary cancer;
  • Known hypersensitivity to sodium porphyrin or other photosensitizing agents;
  • Diffuse liver metastases or liver tumor burden exceeding 50% of liver volume;
  • Known or suspected brain metastases, leptomeningeal metastases, or spinal cord compression (including asymptomatic cases and those adequately treated);
  • Subjects who participated in any other drug clinical trial or other interventional clinical trial within 4 weeks prior to study drug administration, except for subjects participating in observational (non-interventional) clinical studies or those already in the follow-up period of an interventional study;
Show all 38Show fewer
  • Previous exposure to photosensitizers or photodynamic therapy;
  • Patients with unremovable stents in the extrahepatic bile ducts;
  • Patients with prior history of immunotherapy (including but not limited to various anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, etc.), gemcitabine, or cisplatin treatment;
  • Subjects who underwent major surgery within 4 weeks prior to study drug administration;
  • Subjects who used Chinese herbal medicines with immunomodulatory or antitumor effects within 14 days prior to study drug administration;
  • Subjects with advanced cholangiocarcinoma in a cachectic state or who are not expected to tolerate photodynamic therapy;
  • Patients with Bismuth Type IV hilar cholangiocarcinoma;
  • Individuals unsuitable for ERCP or endoscopic procedures;
  • Subjects requiring concomitant antitumor therapy during study drug treatment, including chemotherapy regimens other than GC, radiotherapy, immunotherapy, or biologic agents;
  • Any other malignancy diagnosed within 5 years prior to the first study drug administration, except for any type of carcinoma in situ, micro- or low-risk papillary thyroid carcinoma, and cured basal cell carcinoma or squamous cell carcinoma of the skin;
  • History of allogeneic organ transplantation, or known history of autologous or allogeneic hematopoietic stem cell transplantation;
  • Presence of clinically significant (malignant/cancerous, or moderate to large volume) pleural effusion, ascites, or pericardial effusion within 4 weeks prior to the first dose of porphyrin sodium; however, subjects with only small amounts of effusion (untreated) identified by imaging may be eligible;
  • Presence of acute inflammation (especially necrotizing inflammation) or clinically significant active infection;
  • Hepatitis C virus (HCV) RNA positive, active syphilis, or positive results for any one or more of the following: human immunodeficiency virus (HIV) antibody test, or active hepatitis B (defined as HBV DNA ≥ 2000 IU/mL or HBV DNA ≥ 10⁴ copies);
  • Clinically significant cardiovascular disease or conditions, including but not limited to:
  • Myocardial infarction within 6 months prior to first dosing;
  • Uncontrolled angina pectoris within 3 months prior to first dosing;
  • History or current presence of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) or other ≥ Grade 2 persistent arrhythmias (per NCI-CTCAE v5.0);
  • History or current presence of congestive heart failure [New York Heart Association (NYHA) Class III or IV (Appendix 5)];
  • Complete left bundle branch block or complete right bundle branch block with left anterior fascicular block (double bundle branch block);
  • Long QT syndrome or confirmed family history of long QT syndrome; known concomitant use of QT-prolonging medications;
  • Bradycardia, defined as a screening ECG showing a heart rate < 45 beats per minute;
  • Hypotension, defined as a screening systolic blood pressure ≤86 millimeters of mercury (mmHg);
  • Uncontrolled hypertension, where the subject receives standard antihypertensive therapy but has a screening systolic blood pressure > 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
  • Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attacks), cranial surgery, or unexplained loss of consciousness within 6 months prior to the first dose;
  • Severe pre-existing conditions such as interstitial lung disease, severe dyspnea occurring at rest or requiring supplemental oxygen, inability to lie flat due to acute asthma exacerbation or respiratory failure, active or chronic liver disease, severe hepatic impairment [Child-Pugh Class C], hemorrhagic disorders secondary to hepatic insufficiency, hepatic encephalopathy, etc.; epilepsy or conditions likely to induce seizures; diseases requiring systemic immunosuppressive therapy [including immunosuppressants such as anti-TNF monoclonal antibodies, glucocorticoids (nasal inhalation or topical application permitted)]; history of adrenal insufficiency;
  • Thromboembolic disease within 6 months prior to first dose;
  • Uncontrolled psychiatric illness/social circumstances expected to limit compliance with study requirements or impair the subject's ability to provide written informed consent;
  • Known history of psychiatric drug abuse or substance abuse;
  • Pregnant or lactating women;
  • Receipt of a live vaccine within 4 weeks prior to the first dose;
  • Other reasons deemed by the investigator to make the subject unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

yu xin Xue contact

13151915398

xinyu.xue@shgsmed.com

China1 site, 1 recruiting

  • No. 266, Trumpet Vine Road

    Shanghai, Pudong New Area, 200120

    yu xin Xue, 13151915398, xinyu.xue@shgsmed.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-Label, Phase IIa Clinical Study Evaluating the Preliminary Efficacy and Safety of Sodium Porphyrin Injection Combined With Photodynamic Therapy Plus Gemcitabine and Cisplatin Chemotherapy in Patients With Advanced Extrahepatic Cholangiocarcinoma With Biliary Obstruction

Study Design: Multicenter, open-label, Single Group Study Population: Patients with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma who are inoperable or unwilling to undergo surgery.

Primary Research Objective: To preliminarily evaluate the efficacy of photodynamic therapy (PDT) with sodium protoporphyrin combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma complicated by biliary obstruction.

Read more

Secondary Study Objective: To preliminarily evaluate the safety and tolerability of photodynamic therapy (PDT) with heme porphyrin sodium combined with gemcitabine and cisplatin (GC regimen) chemotherapy in patients with advanced extrahepatic cholangiocarcinoma with biliary obstruction.

Primary endpoint: 6-month overall survival rate (6m-OS rate)

Being tested
Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection, Cisplatin for injection
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.

  • Cosiporfin Sodium for injection, DVDMSDrug

    Dosage: 0.2 mg/kg Storage: 2-8°C. Protect from light. Specifications: 10mg per bottle

  • Gemcitabine Hydrochloride for InjectionDrug

    Specifications: 1.0g/vial, 5 vials/box Storage: Store at room temperature (15-30°C) Dosage: 1000mg/m²

  • Cisplatin for injectionDrug

    Specifications: 20mg/vial, 8 vials/box Storage: Store in a light-protected, tightly closed container (10-30°C) Dosage: 25mg/m²

Study groups in NCT07398339
Study groupRoleWhat they receive
Cosiporfin Sodium for injection Combination Therapy GroupExperimentalCosiporfin Sodium for injection Photodynamic Therapy Combined with Gemcitabine and Cisplatin Chemotherapy
Receives: Drug: Cosiporfin Sodium for injection, DVDMS; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month overall survival rate (6m-OS rate)

    Measured: Month 6

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    Measured: Month 12&Month 24

  2. Disease Control Rate (DCR)

    Measured: Month 12&Month 24

  3. Progression-Free Survival (PFS)

    Measured: Month 12&Month 24

  4. Duration of Response (DoR)

    Measured: Month 12&Month 24

  5. Overall Survival (OS)

    Measured: Month 12&Month 24

  6. 12/24-Month Survival Rate

    Measured: Month 12&Month 24

  7. Time to First Chemotherapy

    Measured: Month 12&Month 24

  8. Time to Jaundice Recurrence/Recurrence Rate

    Measured: Month 12&Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start31 Mar 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398339
Sponsor's protocol ID
GS101-BTC-II-1
Acronym
DVDMS
Status last verified
Feb 2026
First submitted
27 Jan 2026
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cosiporfin Sodium for injection, DVDMS, Gemcitabine Hydrochloride for Injection and Cisplatin for injection in people with Biliary Tract Cancers (BTC), run by Shanghai Guangsheng Biopharmaceutical 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 16 inclusion and 38 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 9 Feb 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 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 yu xin Xue (13151915398, xinyu.xue@shgsmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month overall survival rate (6m-OS rate) (time frame: Month 6). 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 NCT07398339.

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 9 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in