Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectable Advanced/Metastatic Cholangiocarcinoma

Starting soon · Phase 2

Conditions studied: ORR,OS,PFS

In brief

Evaluation of Efficacy and Safety of Sintilimab Plus Bevacizumab and AG Regimen as First-Line Therapy in Patients with Surgically Ineligible Locally Advanced or Metastatic Cholangiocarcinoma Objectives: Primary Objective: To assess the objective response rate (ORR) as per RECIST v1.1. Secondary Objectives: 1. To evaluate the disease control rate (DCR) per RECIST v1.1. 2. To determine the duration of response (DOR) per RECIST v1.1. 3. To measure progression-free survival (PFS) per RECIST v1.1. 4. To characterize the safety profile. 5. To determine overall survival (OS) . Exploratory Objectives: To investigate potential predictive biomarkers (e.g., PD-L1 expression, tumor mutational burden \[TMB\]) and their correlation with treatment efficacy (non-mandatory).

Key facts

Study ID

NCT07328802

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

25

Starts

2026-01-01

Expected to finish

2028-09-30

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent prior to any trial-related procedures.
• Male or female aged **≥18 years and ≤75 years**.
• Histologically or cytologically confirmed, surgically unresectable locally advanced or metastatic cholangiocarcinoma.
• No prior systemic therapy; subjects who completed postoperative adjuvant therapy **>6 months ago** are eligible.
• Life expectancy >3 months.
• At least one measurable lesion per RECIST 1.1 criteria.
• ECOG PS score 0 or 1.
• Adequate organ function (all laboratory criteria below must be met):
• （1）Absolute neutrophil count (ANC) **≥1.5×10⁹/L** without granulocyte colony-stimulating factor within 14 days; （2）Platelets **≥90×10⁹/L** without transfusion within 14 days; （3）Hemoglobin **>9 g/dL** without transfusion/recombinant erythropoietin within 14 days; （4）Total bilirubin ≤1.5×ULN; （5）AST/ALT ≤2.5×ULN (≤5×ULN allowed if liver metastases present); （6）Serum creatinine ≤1.5×ULN AND creatinine clearance (Cockcroft-Gault formula) **≥60 mL/min**; （7）INR or PT ≤1.5×ULN; （8）TSH within normal range; OR if abnormal, total T3 (or FT3) AND FT4 within normal limits; （9）Cardiac enzymes within normal limits (isolated abnormalities deemed clinically insignificant by investigator are allowed).
• For women of childbearing potential:
• （1）Negative urine/serum pregnancy test within 3 days before Cycle 1 Day 1 (confirm equivocal urine tests with serum testing).
• （2）Non-childbearing potential defined as:
• Postmenopausal (≥1 year amenorrhea), OR
• Surgically sterilized/hysterectomy. 10. All subjects (regardless of gender) at conception risk must use contraception with <1% annual failure rate during treatment and for 120 days after last dose.

You may not qualify if…

• Other malignancies within 5 years prior to first dose (excluding radically cured basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ).
• Current participation in interventional clinical trials or receipt of other investigational drugs/devices within 4 weeks before first dose.
• Prior therapy with:
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• Anti-PD-1/PD-L1/PD-L2 agents;
• Drugs targeting stimulatory/co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
• Systemic administration of antitumor Chinese herbal medicines or immunomodulators (e.g., thymosin, interferon, interleukin) within 2 weeks (except localized use for pleural effusion).
• Active autoimmune disease requiring systemic treatment within 2 years (e.g., disease-modifying drugs, corticosteroids ≥10 mg/day prednisone equivalent, immunosuppressants).
• Exclusions: Hormone replacement (thyroxine/insulin/physiologic steroids);
• Known primary immunodeficiency;
• Isolated autoantibody positivity requires investigator confirmation of no autoimmune disease.
• Systemic glucocorticoids (excluding topical/inhaled) or immunosuppressive therapy within 4 weeks.Note: Physiologic-dose steroids (≤10 mg/day prednisone equivalent) permitted.
• Prior anti-angiogenic therapy (e.g., bevacizumab). 8. Active bleeding within 3 months prior to first dose:
• Hemoptysis (≥2.5 mL/fresh blood episode);
• Gastrointestinal bleeding. 9. High bleeding risk: Tumor invasion of major vessels or radiologist/investigator-assessed bleeding tendency.
• Major surgery within 4 weeks (excluding biopsy). 11. Severe unhealed wounds/ulcers/fractures. 12. Aspirin (>325 mg/day) or platelet-inhibiting NSAIDs for >10 consecutive days within 10 days prior to first dose.
• Full-dose anticoagulants/thrombolytics for >10 consecutive days within 10 days prior to first dose.Note: Prophylactic low-dose anticoagulants allowed:
• （1）Warfarin ≤1 mg/day (INR ≤1.5); （2）Heparin ≤12,000 U/day; （3）Aspirin ≤100 mg/day. 14. Hereditary bleeding disorders, coagulopathy, or thrombotic history. 15. Clinically uncontrolled pleural effusion/ascites (asymptomatic/minimal fluid without drainage allowed).
• Allogeneic organ transplant (excluding corneas) or hematopoietic stem cell transplant.
• Hypersensitivity to sintilimab/bevacizumab or excipients. 18. Inadequate recovery from prior intervention toxicities (i.e., >Grade 1 or not returned to baseline, excluding alopecia/fatigue).
• HIV infection (HIV 1/2 antibody-positive). 20. Untreated active HBV:
• HBsAg-positive AND HBV-DNA > local ULN;
• Exceptions:
• a. HBV-DNA <500 IU/mL with ongoing antiviral therapy; b. Anti-HBc (+) only with HBV-DNA monitoring. 21. Active HCV infection (HCV antibody-positive AND detectable HCV-RNA). 22. Live attenuated vaccines within 4 weeks prior to first dose. 23. Pregnancy or breastfeeding. 24. Uncontrolled systemic diseases, including:
• Severe uncontrolled cardiac arrhythmias (e.g., complete LBBB, ≥Grade II AV block, VT/AF);

Where it is running

• the Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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