Gallbladder CancerPhase 2NCT05757336
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
A Phase 2 study testing Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab in people with Gallbladder Cancer and Initially Unresectable, run by Lu Wang, MD, PhD at 1 site in China.
Trial summary
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer, Initially Unresectable, the First Line Treatment
- What is being tested?
- Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2022to 22 Dec 2026
- 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
- 1. Before the implementation of any trial-related procedures, sign a written informed consent 2. Male or female ≥18 years old, ≤75 years old 3. Gallbladder carcinoma confirmed by histology or cytology 4. No previous systemic anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.) 5. Expected survival time > 3 months 6. At least 1 measurable lesion according to RECIST1.1 criteria 7. ECOG PS score of 0-1 8. Sufficient organ function, the subject needs to meet the following laboratory indicators:
- Absolute value of neutrophils (ANC) ≥ 1.5x109/L and platelets ≥ 90×109/L without using granulocyte colony-stimulating factor in the past 14 days;
- Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 21 days;
- Total bilirubin ≤ 3 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN);
- Alkaline phosphatase (AKP) ≤2.5×ULN
Show all 10Show fewer
- Creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥ 50 ml/min;
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH ≤ 10) within the normal range; thyroid dysfunction without clinical significance after thyroid hormone supplementation can also be included.
- Myocardial enzyme spectrum is within the normal range (such as simple laboratory abnormalities that are judged by the investigator to have no clinical significance are also allowed to enter the group); 9. For female subjects of childbearing age, they should receive a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test will be ordered. Women of non-reproductive age are defined as postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy 10. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use contraceptive measures with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration
Who cannot join
- Other malignant diseases outside the biliary tract diagnosed within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically resected carcinoma in situ, radically cured thyroid papillary carcinoma can also be included after surgery);
- Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration;
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred before the first dose. Replacement therapies (eg, thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Only patients with autoimmune antibody positive need to confirm whether there is an autoimmune disease according to the investigator's judgment;
- Active hemoptysis (spitting up at least 2.5ml or 1/2 teaspoon of fresh blood) within 3 months before the first study drug administration, and active gastrointestinal bleeding within 3 months before administration;
- Imaging shows tumor invasion/infiltration of large blood vessels or bleeding tendency assessed by researchers or radiologists;
- Received major surgical treatment within 4 weeks before the first study drug administration (except for surgery for biopsy);
Show all 21Show fewer
- Severe unhealed wound ulcers or fractures;
- Current or recent (within 10 days before receiving the first dose of the study drug) use of aspirin (>325mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days;
- Current or recent (within 10 days before receiving the first dose of study drug) treatment with full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days Note: The prophylactic use of small doses of anticoagulants is allowed: on the premise that the international normalized ratio (INR) of prothrombin time is ≤1.5, small doses of warfarin (≤1 mg/d) and low doses of heparin are allowed for prophylactic purposes (≤12,000 U/d) or low-dose aspirin (≤100mg/d);
- Have hereditary bleeding tendency or coagulation disorder, or history of thrombosis;
- Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other routes of topical glucocorticoid) or any other form of immunosuppressive therapy within 4 weeks before the first dose of the study Note: Physiological doses of glucocorticoids are permitted (≤10 mg/day of prednisone or equivalent)
- There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need drainage or stop drainage for 3 days without significant increase in effusion can be enrolled)
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Those who are known to be allergic to active ingredients or excipients of the study drug sintilimab, bevacizumab, gemcitabine hydrochloride for injection, paclitaxel for injection (albumin-bound type)
- Has not recovered adequately from any intervention-induced toxicity and/or complications (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive)
- Untreated active hepatitis B (defined as HBsAg positive and detection of HBV-DNA copy number greater than the upper limit of normal value of the laboratory laboratory of the research center)
- Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
- If the HBV viral load before the first administration is <2.5×103 copies/ml (500 IU/ml), the subject should receive anti-HBV treatment during the entire study treatment period
- For subjects whose anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load are less than the upper limit of normal value in the laboratory department of the research center, they do not need to receive preventive anti-HBV treatment, but they need to be closely monitored. Monitoring for viral reactivation 18. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection) 19. Except for those who have received live attenuated vaccines within 4 weeks before the first dose of the new crown vaccine 20. Pregnant or lactating women 21. Esophageal or gastric variceal bleeding events caused by portal hypertension in the past 6 months; known severe (G3) varices in endoscopy within 3 months before the first administration; evidence of portal hypertension (including Imaging examination revealed that the length of splenomegaly exceeds 10 cm and the platelets are less than 100×109/L), and the researchers evaluated the risk of bleeding as high 22. Any life-threatening bleeding events occurred in the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, continuous drug therapy 23. Arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious history of thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, unless the thrombus is stabilized after conventional anticoagulant therapy 24. History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colon resection or extensive small bowel resection, complicated by chronic diarrhea) within the past 6 months , Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 25. Presence of any serious or uncontrolled systemic disease, such as:
- 1) Resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are severe and uncontrollable, such as complete left bundle branch block, heart block above second degree, ventricular arrhythmia or with fast ventricular rate atrial fibrillation 2) Unstable angina, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months before the selected treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; 4) Received major surgical operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks before the first administration. Received tissue biopsy or other minor surgical procedures within 7 days before the first dose, except for venipuncture for intravenous infusion 5) Unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) 6) Active tuberculosis 7) Active or uncontrolled infection requiring systemic therapy 8) Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction 9) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis 10) Poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L) 11) Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity > 1.0 g; 12) Patients with mental disorders who cannot cooperate with treatment 26. Medical history or disease evidence that may interfere with the test results, prevent the subject from participating in the whole study, abnormal treatment or laboratory test values, or other situations that the investigator believes are not suitable for enrollment. The investigator believes that there are other potential risks t
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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Lu Wang, +8618121299357, w.lr@hotmail.com
About this study
Official title: Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics of enrolled patients: Patients with initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15 patients in the first stage, and if more than 4pts response, enlarge the sample size to 45 patients in total; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 9 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until the subject died, lost follow-up or the end of the study.
- Being tested
- Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and BevacizumabDrug
Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| combined treatment group | Experimental | Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab GC regimen: up to the results of safety run-in stage
* Dose A: gemcitabine 1000mg/m2, paclitaxel for injection (albumin-bound) 125mg/m2 iv Q3W
* Dose B: gemcitabine 800mg/m2, paclitaxel for injection (albumin-bound) 100mg/m2 iv Q3W
Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 7.5mg/kg, d1, q3w Receives: Drug: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
objective response rate
Measured: 9 weeks
Safety：the incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Measured: 3 weeks
Secondary outcomes (4)
disease control rate
disease control rate
Measured: 3 weeks
progress-free survival
progress-free survival
Measured: 3 weeks
overall survival
overall survival
Measured: 3 weeks
Proportion of acceptable radical resection of primary lesions
Proportion of acceptable radical resection of primary lesions
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start22 Dec 2022
- Primary completion22 Dec 2024 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lu Wang, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lu Wang, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757336
- Sponsor's protocol ID
- GWK-2022-08
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05757336
- Acronym / sponsor ID
- GWK-2022-08
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lu Wang, MD, PhDUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 7 Mar 2023 (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.
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics of enrolled patients: Patients with initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15 patients in the first stage, and if more than 4pts response, enlarge the sample size to 45 patients in total; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 9 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until the subject died, lost follow-up or the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined treatment group | Experimental | Drug: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and BevacizumabCombination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab GC regimen: up to the results of safety run-in stage * Dose A: gemcitabine 1000mg/m2, paclitaxel for injection (albumin-bound) 125mg/m2 iv Q3W * Dose B: gemcitabine 800mg/m2, paclitaxel for injection (albumin-bound) 100mg/m2 iv Q3W Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 7.5mg/kg, d1, q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Before the implementation of any trial-related procedures, sign a written informed consent 2. Male or female ≥18 years old, ≤75 years old 3. Gallbladder carcinoma confirmed by histology or cytology 4. No previous systemic anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.) 5. Expected survival time > 3 months 6. At least 1 measurable lesion according to RECIST1.1 criteria 7. ECOG PS score of 0-1 8. Sufficient organ function, the subject needs to meet the following laboratory indicators:
- Absolute value of neutrophils (ANC) ≥ 1.5x109/L and platelets ≥ 90×109/L without using granulocyte colony-stimulating factor in the past 14 days;
- Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 21 days;
- Total bilirubin ≤ 3 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN);
Key exclusion criteria (21 listed)
- Other malignant diseases outside the biliary tract diagnosed within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically resected carcinoma in situ, radically cured thyroid papillary carcinoma can also be included after surgery);
- Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration;
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred before the first dose. Replacement therapies (eg, thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Only patients with autoimmune antibody positive need to confirm whether there is an autoimmune disease according to the investigator's judgment;
- Active hemoptysis (spitting up at least 2.5ml or 1/2 teaspoon of fresh blood) within 3 months before the first study drug administration, and active gastrointestinal bleeding within 3 months before administration;
- Imaging shows tumor invasion/infiltration of large blood vessels or bleeding tendency assessed by researchers or radiologists;
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 |
|---|---|---|
| Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and BevacizumabCombination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab | Drug | combined treatment group |
Primary outcome
objective response rate
Time frame: 9 weeks
objective response rate
Safety：the incidence of adverse events and serious adverse events
Time frame: 3 weeks
Incidence of adverse events and serious adverse events
4 secondary outcomes
disease control rate
Time frame: 3 weeks
progress-free survival
Time frame: 3 weeks
overall survival
Time frame: 3 weeks
Proportion of acceptable radical resection of primary lesions
Time frame: 3 weeks
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 7 Mar 2023.
Related trials for Gallbladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
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 Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab in people with Gallbladder Cancer and Initially Unresectable, run by Lu Wang, MD, PhD 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 10 inclusion and 21 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 7 Mar 2023. 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 Lu Wang (+86-18121299357, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 9 weeks). The study lists 2 primary outcomes in all. 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 7 Mar 2023.