ORR,OS,PFSPhase 2NCT07328802
Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectable Advanced/Metastatic Cholangiocarcinoma
A Phase 2 study testing Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine in people with ORR,OS,PFS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ORR,OS,PFS
- What is being tested?
- Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- 9. 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.
Who cannot join
- 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:
- <!-- -->
- Anti-PD-1/PD-L1/PD-L2 agents;
- Drugs targeting stimulatory/co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
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- 4. Systemic administration of antitumor Chinese herbal medicines or immunomodulators (e.g., thymosin, interferon, interleukin) within 2 weeks (except localized use for pleural effusion).
- 5. 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.
- 6. Systemic glucocorticoids (excluding topical/inhaled) or immunosuppressive therapy within 4 weeks.Note: Physiologic-dose steroids (≤10 mg/day prednisone equivalent) permitted.
- 7. 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.
- 10. 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.
- 13. 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).
- 16. Allogeneic organ transplant (excluding corneas) or hematopoietic stem cell transplant.
- 17. 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).
- 19. HIV infection (HIV 1/2 antibody-positive). 20. Untreated active HBV:
- HBsAg-positive AND HBV-DNA > local ULN;
- Exceptions:
- 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);
- Unstable angina, CHF, NYHA Class ≥II heart failure;
- Arterial thromboembolism within 6 months (e.g., MI, stroke, TIA);
- Major surgery/unhealed wounds within 4 weeks; biopsy within 7 days (except IV catheterization);
- Uncontrolled hypertension (>140/90 mmHg);
- Active tuberculosis;
- Uncontrolled systemic infection;
- Clinical diverticulitis, intra-abdominal abscess, GI obstruction;
- Decompensated liver disease/active hepatitis;
- Uncontrolled diabetes (fasting glucose >10 mmol/L);
- Urine protein ≥++ AND 24-hr urine protein >1.0 g. 25. Psychiatric disorders impairing treatment compliance. 26. Any condition that may:
- （1）Interfere with trial results; （2）Prevent full study participation; （3）Pose additional risks (per investigator judgment).
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
the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jin Yun, 86+13588140070, william99@126.com
About this study
Official title: Clinical Study Protocol for a Single-Center, Prospective, Single-Arm Trial Assessing Icaritin Soft Capsules as Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
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:
Read more
Primary Objective:
To assess the objective response rate (ORR) as per RECIST v1.1.
Secondary Objectives:
- To evaluate the disease control rate (DCR) per RECIST v1.1.
- To determine the duration of response (DOR) per RECIST v1.1.
- To measure progression-free survival (PFS) per RECIST v1.1.
- To characterize the safety profile.
- 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).
Read the detailed description
This study is a single-arm, Phase II clinical trial evaluating the efficacy and safety of Sintilimab plus Bevacizumab and the AG regimen as first-line therapy in patients with surgically ineligible locally advanced or metastatic cholangiocarcinoma.
After providing informed consent, patients receive:
Sintilimab: 200 mg IV Q3W Bevacizumab: 15 mg/kg IV Q3W AG Chemotherapy: Nab-paclitaxel + Gemcitabine for 8 cycles.
Post-chemotherapy, patients continue Sintilimab + Bevacizumab maintenance until:
Disease progression Death Intolerable toxicity Withdrawal of consent Initiation of new antitumor therapy Other protocol-specified reasons (Maximum treatment duration: 24 months)
- Conditions
- ORR,OS,PFS
- Being tested
- Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabineDrug
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 group | Role | What they receive |
|---|---|---|
| Study Cohort | Other | Not described Receives: Drug: Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline (within 28 days prior to enrollment) through disease progression or study completion, up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ORR,OS,PFSStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328802
- Sponsor's protocol ID
- CHOL-Sintilimab-Bevacizumab-AG
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for a Single-Center, Prospective, Single-Arm Trial Assessing Icaritin Soft Capsules as Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence
- ClinicalTrials.gov ID
- NCT07328802
- Acronym / sponsor ID
- CHOL-Sintilimab-Bevacizumab-AG
- Conditions
- ORR,OS,PFS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Jan 2026 (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.
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:
- To evaluate the disease control rate (DCR) per RECIST v1.1.
- To determine the duration of response (DOR) per RECIST v1.1.
- To measure progression-free survival (PFS) per RECIST v1.1.
- To characterize the safety profile.
- 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).
Detailed description
This study is a single-arm, Phase II clinical trial evaluating the efficacy and safety of Sintilimab plus Bevacizumab and the AG regimen as first-line therapy in patients with surgically ineligible locally advanced or metastatic cholangiocarcinoma.
After providing informed consent, patients receive:
Sintilimab: 200 mg IV Q3W Bevacizumab: 15 mg/kg IV Q3W AG Chemotherapy: Nab-paclitaxel + Gemcitabine for 8 cycles.
Post-chemotherapy, patients continue Sintilimab + Bevacizumab maintenance until:
Disease progression Death Intolerable toxicity Withdrawal of consent Initiation of new antitumor therapy Other protocol-specified reasons (Maximum treatment duration: 24 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | Other | Drug: Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (36 listed)
- <!-- -->
- 4. Systemic administration of antitumor Chinese herbal medicines or immunomodulators (e.g., thymosin, interferon, interleukin) within 2 weeks (except localized use for pleural effusion).
- 5. Active autoimmune disease requiring systemic treatment within 2 years (e.g., disease-modifying drugs, corticosteroids ≥10 mg/day prednisone equivalent, immunosuppressants).
- 6. Systemic glucocorticoids (excluding topical/inhaled) or immunosuppressive therapy within 4 weeks.Note: Physiologic-dose steroids (≤10 mg/day prednisone equivalent) permitted.
- 7. Prior anti-angiogenic therapy (e.g., bevacizumab). 8. Active bleeding within 3 months prior to first dose:
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 |
|---|---|---|
| Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabinePatients 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. | Drug | Study Cohort |
Primary outcome
Objective Response Rate (ORR)
Time frame: From baseline (within 28 days prior to enrollment) through disease progression or study completion, up to approximately 2 years.
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
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 9 Jan 2026.
- 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 Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine in people with ORR,OS,PFS, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 14 inclusion and 36 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 9 Jan 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 Jin Yun (+8613588140070, william99@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From baseline (within 28 days prior to enrollment) through disease progression or study completion, up to approximately 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.