Advanced Pancreatic CancerPhase 2NCT06329947
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
A Phase 2 study testing Surufatinib 250mg/d qd once daily in people with Advanced Pancreatic Cancer, run by Rui-hua Xu, MD, PhD at 1 site in China.
Trial summary
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Surufatinib 250mg/d qd once daily
- 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
- 22 May 2024to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Have full understanding of this study and voluntarily sign the informed consent form;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed metastatic pancreatic cancer;
- Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy;
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Predicted survival ≥12 weeks;
- Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
Who cannot join
- Participated in other anti-tumor drug clinical trials within 28 days;
- Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
- Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
- Those who are known to be allergic to any of the drugs in the study;
- Brain metastasis accompanied by symptoms or symptom control time <2 months;
- The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);
Show all 21Show fewer
- Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
- Absolute neutrophil count (ANC) <1.5×109/L;
- Platelets <100×109/L;
- Hemoglobin <8g/dL.
- Liver abnormalities:
- When there is no liver metastasis, ALT, AST or ALP>2.5×the upper limit of the normal reference range (ULN); when there is liver metastasis, ALT, AST or ALP>5×ULN;
- Serum total bilirubin >1.5×ULN (Gilber syndrome >3×ULN);
- Decompensated cirrhosis (Child-Pugh liver function grade B or C);
- Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000IU/mL (those who are HBsAg positive and hepatitis B virus DNA copy number <2000IU/mL need to receive at least 2 weeks of anti-HBV treatment before taking the first dose) ;
- Hepatitis C virus (HCV) antibody positive and HCVRNA test positive.
- Kidney abnormalities:
- Serum creatinine>1.5×ULN;
- Routine urine test shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be >1.0g;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Past history of nephrotic syndrome.；
Trial locations and contacts
1 site in 1 country.
About this study
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer
Read the detailed description
Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Surufatinib 250mg/d qd once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib 250mg/d qd once dailyDrug
Also called Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 years
mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Surufatinib in combination with Camrelizumab and mFOLFOX6 Receives: Drug: Surufatinib 250mg/d qd once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Measured: Time Frame: up to 24 months
Secondary outcomes (5)
disease control rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Measured: Time Frame: up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Measured: Time Frame: up to 24 months
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Measured: Time Frame: up to 24 months
quality of life (QoL)
Assessing the quality of life of cancer patients by QLQ-C30
Measured: Time Frame: up to 24 months
adverse events (AE)
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measured: Time Frame: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start22 May 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rui-hua Xu, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
- Investigators
- Rui Hua Xu, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329947
- Sponsor's protocol ID
- HMPL-012-SPRING-P106
- Status last verified
- May 2024
- First submitted
- 5 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
- ClinicalTrials.gov ID
- NCT06329947
- Acronym / sponsor ID
- HMPL-012-SPRING-P106
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Rui-hua Xu, MD, PhDUniversity, hospital or other
- Study start
- 22 May 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Mar 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.
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer
Detailed description
Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Surufatinib 250mg/d qd once dailySurufatinib in combination with Camrelizumab and mFOLFOX6 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have full understanding of this study and voluntarily sign the informed consent form;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed metastatic pancreatic cancer;
- Patients who have previously failed first-line gemcitabine-based chemotherapy or have disease progression/recurrence during previous neoadjuvant/adjuvant treatment or within 6 months after the end of treatment are considered to have failed first-line systemic chemotherapy; neoadjuvant/adjuvant treatment plan Also gemcitabine-based chemotherapy;
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
Key exclusion criteria (21 listed)
- Participated in other anti-tumor drug clinical trials within 28 days;
- Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
- Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
- Those who are known to be allergic to any of the drugs in the study;
- Brain metastasis accompanied by symptoms or symptom control time <2 months;
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 |
|---|---|---|
| Surufatinib 250mg/d qd once dailyAlso: Camrelizumab 200mg,IV,Q2W once every 21 days during the maintenance treatment period, for a maximum of 2 yearsmFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles. | Drug | Experimental group |
Primary outcome
objective response rate (ORR)
Time frame: Time Frame: up to 24 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
5 secondary outcomes
disease control rate (DCR)
Time frame: Time Frame: up to 24 months
Progression-Free Survival (PFS)
Time frame: Time Frame: up to 24 months
overall survival (OS)
Time frame: Time Frame: up to 24 months
quality of life (QoL)
Time frame: Time Frame: up to 24 months
adverse events (AE)
Time frame: Time Frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Not yet recruitingObservational study
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer
Pancreatic Cancer, Advanced or Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
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. This study is not recruiting at the moment.
Rui Hua Xu, MD principal investigator
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 Surufatinib 250mg/d qd once daily in people with Advanced Pancreatic Cancer, run by Rui-hua Xu, 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 8 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Hua Xu, MD (13922206676, xurh@sysucc.org.cn), 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: Time Frame: up to 24 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 8 May 2024.