Unresectable Gallbladder CancerPhase 2NCT06423170
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs
A Phase 2 study testing Camrelizumab plus GEMOX in people with Unresectable Gallbladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Gallbladder Cancer
- What is being tested?
- Camrelizumab plus GEMOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2027
- 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
- Patients aged 18-75 years
- Patients with unresectable gallbladder cancer clearly diagnosed by puncture pathology or the presence of tumour cells in the bile
- No history of chemotherapy or immunotherapy
- ECOG score 0-1 within 1 week prior to enrollment
- Expected survival > 3 months
- The functional indicators of important organs meet the following requirements： (1)Neutrophils≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min(calculated by Cockcroft-Gault formula);
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- Female subjects of childbearing potential must have had a negative serum pregnancy study within 14 days prior to the start of study treatment and be willing to use a reliable method of contraception during the study and for 60 days after the final administration of study drug
- Male subjects whose partner is a woman of childbearing age should agree to use a reliable method of contraception for the duration of the study and for 120 days after the last dose of study drug
- Subjects who voluntarily enter the study, sign an informed consent form, are compliant and willing to cooperate with follow-up
Who cannot join
- Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
- Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2measurements);
- Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
- After antiviral treatment, HBV DNA>2000 copies/ml, HCV RNA>1000;
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- A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
- Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
- Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
- A history of psychotropic drug abuse, alcohol or drug abuse;
- Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;
- Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors. -
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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510288
Zhang Rui, PhD, 020-34078840, zhangr95@mail.sysu.edu.cn
About this study
Official title: Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial
The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study.
- Conditions
- Unresectable Gallbladder Cancer
- Being tested
- Camrelizumab plus GEMOX
- Keywords
- PD-1；GEMOX；Unresectable gallbladder cancer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab plus GEMOXDrug
- Camrelizumab：200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes.
- GEMOX chemotherapy : oxaliplatin 100mg/m2，D1, gemcitabine1000mg/m2，D1，intravenous infusion.
- Carrilizumab and GEMOX chemotherapy will be intravenous infused atone day. Three weeks is a course of treatment,a total of 6-8 courses.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus GEMOX | Experimental | Camrelizumab plus GEMOX was given as conversion therapy for unresectable gallbladder cancer Receives: Drug: Camrelizumab plus GEMOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
radical tumor resection rate
The proportion of patients with negative surgical resection margins in the study group
Measured: 6 months
Secondary outcomes (4)
Disease Control Rate，DCR
The proportion of patients whose tumours shrink or remain stable for a certain period of time and includes cases of complete remission (CR), partial remission (PR) and stable (SD).
Measured: 6 months
Progress Free Survival，PFS
The time between the start of treatment for disease and the observation of disease progression or the occurrence of death from any cause
Measured: 6 months
Overall Survival，OS
The time between the start of the diagnosis of unresectable gallbladder cancerand death from any cause
Measured: 6 months
Objective response rate，ORR
The proportion of patients whose tumour volume shrinks to a pre-defined value and who are able to maintain the minimum time requirement is the sum of the proportion in complete remission (CR) and partial remission (PR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 37 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Rui, PhD, Study chair, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423170
- Sponsor's protocol ID
- SYSKY-2022-516
- Status last verified
- Aug 2026
- First submitted
- 15 May 2024
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Gemcitabine and Oxaliplatin (GEMOX) in Patients for Unresectable Gallbladder Cancer: a Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT06423170
- Acronym / sponsor ID
- SYSKY-2022-516
- Conditions
- Unresectable Gallbladder Cancer
- Keywords
- PD-1；GEMOX；Unresectable gallbladder cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 May 2024 (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.
The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin (GEMOX) for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mg/m2 D1+oxaliplatin 100mg/m2, D1+Camrelizumab 200mg, D1, in 21-day cycles for 6-8 cycles, with serum tumour markers assessed at each course and abdominal CTA performed every two courses, until tumour progression occurs.The primary indicators of this study are radical tumor resection rate; secondary indicators are disease control rate, objective response rate,progression-free survival and overall survival; safety indicators: incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to NCI-CTCAEv5.0 criteria. 37 patients are expected to be recruited for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab plus GEMOX | Experimental | Drug: Camrelizumab plus GEMOXCamrelizumab plus GEMOX was given as conversion therapy for unresectable gallbladder cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18-75 years
- Patients with unresectable gallbladder cancer clearly diagnosed by puncture pathology or the presence of tumour cells in the bile
- No history of chemotherapy or immunotherapy
- ECOG score 0-1 within 1 week prior to enrollment
- Expected survival > 3 months
Key exclusion criteria (12 listed)
- Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
- Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
- Severe cardiopulmonary and renal dysfunction;
- Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2measurements);
- Abnormal coagulation function (PT>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
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 |
|---|---|---|
| Camrelizumab plus GEMOX1. Camrelizumab：200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : oxaliplatin 100mg/m2，D1, gemcitabine1000mg/m2，D1，intravenous infusion. 3. Carrilizumab and GEMOX chemotherapy will be intravenous infused atone day. Three weeks is a course of treatment,a total of 6-8 courses. | Drug | Camrelizumab plus GEMOX |
Primary outcome
radical tumor resection rate
Time frame: 6 months
The proportion of patients with negative surgical resection margins in the study group
4 secondary outcomes
Disease Control Rate，DCR
Time frame: 6 months
Progress Free Survival，PFS
Time frame: 6 months
Overall Survival，OS
Time frame: 6 months
Objective response rate，ORR
Time frame: 6 months
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 30 Sep 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.
Zhang Rui, PhD study chair
Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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 Camrelizumab plus GEMOX in people with Unresectable Gallbladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 9 inclusion and 12 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 30 Sep 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 Zhang Rui, PhD (020-34078840, zhangr95@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radical tumor resection rate (time frame: 6 months). 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 30 Sep 2026.