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

NCT07328802 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CHOL-Sintilimab-Bevacizumab-AG
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To evaluate the disease control rate (DCR) per RECIST v1.1.
2. 2.To determine the duration of response (DOR) per RECIST v1.1.
3. 3.To measure progression-free survival (PFS) per RECIST v1.1.
4. 4.To characterize the safety profile.
5. 5.To determine overall survival (OS) .

Conditions

ORR,OS,PFS

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Tumor assessments are based on RECIST 1.1. Imaging modalities for this evaluation require: Mandatory scans (each cycle): Contrast-enhanced CT or MRI of the chest and abdomen Baseline assessments (within 28 days ): Contrast-enhanced CT/MRI of the pelvis Brain MRI Whole-body bone scan Additional baseline imaging if clinically indicated: Contrast-enhanced neck CT (if cervical lymphadenopathy present) PET/CT protocol: Acceptable for baseline screening only Any abnormal findings must undergo confirmatory anatomical imaging (CT/MRI) for target lesion designation

  From baseline (within 28 days prior to enrollment) through disease progression or study completion, up to approximately 2 years.

Study Arms (1)

Study Cohort

OTHER

Drug: Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine

Interventions

Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine DRUG

Patients receive sintilimab (200mg IV Q3W) combined with bevacizumab (15mg/kg IV Q3W) and the AG regimen (albumin-bound paclitaxel + gemcitabine). AG chemotherapy is administered for a total of 8 cycles. After completion of chemotherapy, patients continue sintilimab plus bevacizumab maintenance therapy until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for treatment discontinuation, with a maximum treatment duration of 24 months.

Study Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Bevacizumab; Albumin-Bound Paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Jin Yun

CONTACT

+8613588140070; william99@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)