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AzTrials

CholangiocarcinomaPhase 2NCT07296666

Adjuvant Chemotherapy for BTC Based on 3D-PTA

A Phase 2 study testing Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone). and capecitabine alone as adjuvant treatment in people with Cholangiocarcinoma, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective, open-label, controlled, multicenter clinical study designed to observe and evaluate the efficacy and safety of chemotherapy (including capecitabine monotherapy) guided by 3D-PTA drug sensitivity testing versus capecitabine monotherapy as adjuvant treatment in patients with stage II/III… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone). and capecitabine alone as adjuvant treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
No sites listed yet
Study dates
Dec 2025to Oct 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

  • Signing of written informed consent prior to participation;
  • Age ≥18 years, regardless of sex;
  • Histologically confirmed stage II/III biliary tract malignancies (including intrahepatic cholangiocarcinoma, extrahepatic/hilar cholangiocarcinoma, gallbladder cancer, distal bile duct cancer, or ampullary cancer);
  • Must have undergone radical resection (R0/R1), including liver/pancreatic resection or, less commonly, both;
  • ECOG performance status (PS) score: 0-1;
  • Expected survival >6 months and ability to tolerate combined therapy;
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  • Adequate organ function (without blood component or growth factor support within 14 days):
  • Hematology: Neutrophils ≥1,500/mm³, platelets ≥100,000/mm³, hemoglobin ≥9 g/dL;
  • Liver/kidney function: Serum creatinine (SCr) ≤1.5×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤2×ULN; AST/ALT ≤3×ULN; urine protein <2+ (if ≥2+, 24-hour urine protein ≤1 g); Biliary drainage: Adequate surgical drainage, no signs of infection;
  • Normal coagulation function, no active bleeding or thrombotic disease:INR ≤1.5×ULN, APTT ≤1.5×ULN, PT ≤1.5×ULN;
  • Contraception:
  • Non-surgically sterilized or reproductive-age patients must use medically approved contraception (e.g., IUD, oral contraceptives, condoms) during and for 3 months after treatment;
  • Reproductive-age females must have negative serum/urine pregnancy test (HCG) within 7 days before enrollment and must not be breastfeeding;
  • Reproductive-age males must agree to use contraception with partners during and for 3 months after treatment;
  • Voluntary participation, good compliance, and willingness to follow up for safety and survival assessments.

Who cannot join

  • Early-stage BTC patients;
  • Pancreatic cancer patients;
  • Patients who have undergone other postoperative radiotherapy/chemotherapy; preoperative chemoradiotherapy followed by radical resection, but postoperative pathology still indicates Stage II/III disease is allowed;
  • Incomplete surgical recovery or unresolved biliary obstruction;
  • Patients with radiologically confirmed distant metastasis;
  • Patients with a history of or concurrent other malignancies (except for cured basal cell carcinoma of the skin and in-situ carcinoma of other sites);
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  • Known allergies to any component of the investigational drug;
  • Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction;
  • Patients with any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism; patients with vitiligo or childhood asthma that has been completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for medical intervention due to asthma cannot be included);
  • Patients using immunosuppressants or systemic/absorbable local corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks prior to enrollment;
  • Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage;
  • Poorly controlled cardiac symptoms or diseases, such as:
  • NYHA Class II or higher heart failure,
  • unstable angina,
  • myocardial infarction within 1 year,
  • clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • Coagulation abnormalities (PT >16s, APTT >43s, TT >21s, Fbg >2g/L), bleeding tendency, or receiving thrombolytic/anticoagulant therapy;
  • Active infection or unexplained fever >38.5°C during screening or before the first dose;
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before the first dose;
  • History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe lung dysfunction;
  • Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (liver enzymes not meeting inclusion criteria; for hepatitis B: HBV DNA ≥103/ml; for hepatitis C: HCV RNA ≥103/ml); chronic HBV carriers with HBV DNA <2000 IU/ml (<104 copies/ml) may be included if receiving antiviral therapy during the trial;
  • Participation in other drug-related clinical trials within 1 month before enrollment or potential receipt of other systemic anti-cancer therapies during the study;
  • Live vaccination within 4 weeks before the first dose or planned during the study;
  • History of substance abuse, alcoholism, or drug addiction;
  • Inability or unwillingness to bear the cost of self-funded examinations and treatments;
  • Other factors deemed by the investigator to exclude the patient, such as severe diseases (including mental illness) requiring treatment, significant laboratory abnormalities, or family/social factors that may compromise patient safety or data/sample collection.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lu Wang contact

86-13601678615

w.lr@hotmail.com

About this study

Official title: Adjuvant Therapy for Stage II/III Cholangiocarcinoma Based on 3D-PTA Susceptibility Testing: A Prospective, Multicenter, Randomized Controlled Trial

This is a prospective, open-label, controlled, multicenter clinical study designed to observe and evaluate the efficacy and safety of chemotherapy (including capecitabine monotherapy) guided by 3D-PTA drug sensitivity testing versus capecitabine monotherapy as adjuvant treatment in patients with stage II/III cholangiocarcinoma after surgery.

Read the detailed description

All participants underwent baseline disease assessment, including radiological evaluation within 14 days before treatment initiation. The study compared capecitabine combined with 3D-PTA-selected chemotherapy drugs (administered at standard doses) versus capecitabine monotherapy. Participants received study drugs on Day 1 of each cycle for 8 cycles. Tumor efficacy evaluation, vital signs, ECOG performance status (PS) score, physical examination, and quality of life (QoL) assessments were conducted every 9 weeks after the first dose until disease progression, unacceptable toxicity, or participant withdrawal. Adverse event (AE) monitoring and concomitant medication documentation were performed continuously from treatment initiation through 30 days post-treatment. Follow-up included tumor efficacy evaluation and QoL assessment every 6 months, with survival follow-up for participants experiencing disease recurrence or metastasis.

Being tested
Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone)., capecitabine alone as adjuvant treatment
Keywords
BTC
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone).Drug

    Chemotherapy combined with capecitabine (including capecitabine monotherapy) guided by 3D-PTA drug sensitivity testing versus capecitabine alone as adjuvant treatment.

  • capecitabine alone as adjuvant treatmentDrug

    capecitabine alone as adjuvant treatment

Study groups in NCT07296666
Study groupRoleWhat they receive
Treatment group: Capecitabine + 3D-PTA-selected chemotherapy drugs (conventional dosage)ExperimentalNot described
Receives: Drug: Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone).
Control group: CapecitabineActive comparatorNot described
Receives: Drug: capecitabine alone as adjuvant treatment

What is being measured

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

  1. 12-month PFS rate.

    12-month PFS rate.

    Measured: 12-month

Secondary outcomes (2)

  1. median Recurrence-Free Survival（mRFS）

    mRFS

    Measured: 12-month

  2. median Overall Survival（mOS）

    mOS

    Measured: 12-month

Timeline

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

  1. First posted22 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07296666
Sponsor's protocol ID
GWK-2025-008
Status last verified
Oct 2025
First submitted
24 Nov 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy (preferably with a single chemotherapeutic agent) combined with capecitabine (including capecitabine monotherapy: when the preferred drug identified is capecitabine alone). and capecitabine alone as adjuvant treatment in people with Cholangiocarcinoma, run by Fudan University.

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 15 inclusion and 26 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Lu Wang (86-13601678615, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month PFS rate. (time frame: 12-month). 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 NCT07296666.

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 22 Dec 2025.

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