Pancreatic CancerPhase 2NCT07814859
Retlirafusp Alfa Combined With Famitinib, Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Unresectable Pancreatic Cancer
A Phase 2 study testing Retlirafusp alfa Injection, Famitinib and AG in people with Pancreatic Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This is a single-arm, prospective, multicenter, open-label clinical trial, which aims to observe and evaluate the efficacy and safety of Relafen-α combined with famitinib and AG chemotherapy as first-line therapy in patients with unresectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Retlirafusp alfa Injection, Famitinib and AG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Aug 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years, of any gender;
- Histopathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma;
- Unresectable disease or distant metastasis confirmed by imaging evidence. Unresectable pancreatic ductal adenocarcinoma is defined as patients with distant metastasis, or a subset of locally advanced pancreatic cancer (LAPC) with invasion of surrounding major blood vessels that cannot be resected and reconstructed;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- Expected survival ≥ 12 weeks;
- No prior systemic anti-cancer treatment;
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- Adequate function of major organs;
- Baseline hematology and blood biochemistry shall meet the following criteria:
- White blood cell count ≥ 3.0 × 10⁹/L; hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN; albumin ≥ 30 g/L;
- Females of child-bearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for 6 months after study completion, have a negative serum or urine pregnancy test within 7 days prior to enrollment, and shall not be breastfeeding. Male subjects must agree to use effective contraception throughout the study and for 6 months after the end of study treatment;
- Subjects voluntarily participate in this study, provide written informed consent, have good compliance, and are willing to complete follow-up assessments.
Who cannot join
- Subjects with hypersensitivity to Retlirafusp alfa, famitinib, gemcitabine, albumin-bound paclitaxel or their excipients;
- Histopathologically-confirmed other pancreatic malignancies, such as pancreatic acinar cell carcinoma, pancreatic neuroendocrine tumor;
- Moderate-to-large pleural effusion, pericardial effusion or ascites with clinical symptoms, which requires frequent drainage (≥ 1 time per week) as judged by the investigator;
- History of organ transplantation (including autologous bone-marrow transplantation and peripheral stem-cell transplantation);
- Prior receipt of systemic anti-cancer therapy;
- Active or uncontrolled severe infection (≥ Grade 2 infection according to CTCAE 5.0), including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; unexplained fever > 38.5 °C before the first dose;
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- Subjects with a history of psychoactive substance abuse that cannot be discontinued, or with psychiatric disorders;
- History of or concurrent other malignant tumors requiring active treatment within the past 5 years (except for fully-treated basal-cell or squamous-cell skin cancer, carcinoma in situ of the cervix and carcinoma in situ of the breast with an expected 5-year survival rate > 90 %);
- Presence of uncorrectable coagulation disorders;
- Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina or coronary-artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) class ≥ 2 congestive heart failure; ventricular arrhythmias requiring pharmacotherapy (including baseline QTc interval calculated by Fridericia's correction formula (QTcF): ≥ 450 ms for males and ≥ 470 ms for females); left-ventricular ejection fraction (LVEF) < 50 %;
- Subjects with radiologically-confirmed tumor invasion into major blood vessels, or those judged by the investigator to be at high risk of life-threatening massive hemorrhage due to subsequent tumor invasion of major blood vessels during the study;
- Subjects with active autoimmune disease, immunodeficiency, or a medical history including, but not limited to, autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis are excluded. Exceptions: subjects with a history of autoimmune hypothyroidism receiving thyroid-hormone replacement therapy are eligible. Subjects with type 1 diabetes mellitus whose blood-glucose level is well-controlled with insulin regimens may be enrolled;
- Subjects receiving immunosuppressants or systemic corticosteroids for immunosuppressive purposes (> 10 mg/day prednisone or equivalent dose of other glucocorticoids) and continuing such treatment within 2 weeks before enrollment;
- Arterial or venous thromboembolic events within 3 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral embolism), deep-vein thrombosis and pulmonary embolism;
- Gastrointestinal diseases or conditions that, in the investigator's opinion, may affect drug absorption, including but not limited to active gastric/duodenal ulcer, ulcerative colitis, un-resected gastrointestinal tumor with active bleeding, or other conditions at risk of gastrointestinal bleeding or perforation as assessed by the investigator; multiple factors interfering with oral-drug administration (e.g. inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction);
- Uncontrolled hypertension despite medication, defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg;
- Major surgery (excluding biopsy) performed within 28 days prior to enrollment, or incompletely-healed surgical incision;
- Receipt of any other investigational product or participation in another interventional clinical trial within 4 weeks before informed-consent signature;
- Pregnant women (positive pregnancy test before drug administration) or breastfeeding women;
- Subjects deemed unsuitable for enrollment at the investigator's discretion.
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 First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Zhai Wenlong Chief Physician, 13937150977, zhai-wl@hotmail.com
About this study
Official title: A Prospective, Exploratory Study of Retlirafusp Alfa Combined With Famitinib and AG-Chemotherapy as First-Line Therapy for Unresectable Pancreatic Cancer
This is a single-arm, prospective, multicenter, open-label clinical trial, which aims to observe and evaluate the efficacy and safety of Relafen-α combined with famitinib and AG chemotherapy as first-line therapy in patients with unresectable pancreatic cancer.
The study enrolls patients with unresectable locally advanced and metastatic pancreatic cancer.
Read more
Progression-free survival (PFS) is set as the primary efficacy endpoint. Approximately 88 patients with unresectable locally advanced and metastatic pancreatic cancer will be recruited. After adequate informed consent and signature of the informed consent form, eligible screened subjects will receive Relafen-α in combination with famitinib plus nab-paclitaxel/gemcitabine.
Treatment regimen： Relafen-α (1800 mg, q3w, Cycle 1); Famitinib (15 mg, qd, q3w); nab-paclitaxel (125 mg/m², d1, d8, Q3W, for 6 cycles) combined with gemcitabine (1000 mg/m², d1, d8, Q3W, for 6 cycles). Treatment will be continued until disease progression or intolerable toxicity, whichever occurs first.
- Conditions
- Pancreatic Cancer
- Being tested
- Retlirafusp alfa Injection, Famitinib, AG
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa InjectionDrug
etlirafusp alfa (1800 mg, q3w, Cycle 1)，until the disease or toxicity becomes intolerable (whichever comes first)
FamitinibDrug
Famitinib (15mg, once daily, every 3 weeks),until the disease or toxicity becomes intolerable (whichever comes first).
AGDrug
Albumin-bound paclitaxel (125mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) combined with gemcitabine (1000mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) until the disease progresses or toxicity becomes unbearable (whichever happens first).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: Retlirafusp alfa Injection; Drug: Famitinib; Drug: AG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: From date of informed consent until date of first documented progression or death, assessed every 2 cycles (approximately 6 weeks) up to 2 years
Secondary outcomes (5)
Objective Response Rate
Measured: From date of study entry up to 24 months.
Disease Control Rate
Measured: From date of study entry up to 24 months.
Overall Survival
Measured: From date of study entry (signing of informed consent) until death from any cause, assessed up to 24 months after the last patient enrolled.
AE
Measured: From signing of informed consent until 90 days after the last dose of study treatment.
Objective Response Rate
Measured: Objective Response Rate (ORR) defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1, assessed every 2 cycles (approximately 6 weeks) from start of treatment until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- 88 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhai Wenlong, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814859
- Sponsor's protocol ID
- 2026-KY-0839-002
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Study of Retlirafusp Alfa Combined With Famitinib and AG-Chemotherapy as First-Line Therapy for Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07814859
- Acronym / sponsor ID
- 2026-KY-0839-002
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 11 Sep 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.
This is a single-arm, prospective, multicenter, open-label clinical trial, which aims to observe and evaluate the efficacy and safety of Relafen-α combined with famitinib and AG chemotherapy as first-line therapy in patients with unresectable pancreatic cancer.
The study enrolls patients with unresectable locally advanced and metastatic pancreatic cancer.
Progression-free survival (PFS) is set as the primary efficacy endpoint. Approximately 88 patients with unresectable locally advanced and metastatic pancreatic cancer will be recruited. After adequate informed consent and signature of the informed consent form, eligible screened subjects will receive Relafen-α in combination with famitinib plus nab-paclitaxel/gemcitabine.
Treatment regimen： Relafen-α (1800 mg, q3w, Cycle 1); Famitinib (15 mg, qd, q3w); nab-paclitaxel (125 mg/m², d1, d8, Q3W, for 6 cycles) combined with gemcitabine (1000 mg/m², d1, d8, Q3W, for 6 cycles). Treatment will be continued until disease progression or intolerable toxicity, whichever occurs first.
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: Retlirafusp alfa Injection, Drug: Famitinib, Drug: AG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged between 18 and 80 years, of any gender;
- Histopathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma;
- Unresectable disease or distant metastasis confirmed by imaging evidence. Unresectable pancreatic ductal adenocarcinoma is defined as patients with distant metastasis, or a subset of locally advanced pancreatic cancer (LAPC) with invasion of surrounding major blood vessels that cannot be resected and reconstructed;
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
- Expected survival ≥ 12 weeks;
Key exclusion criteria (20 listed)
- Subjects with hypersensitivity to Retlirafusp alfa, famitinib, gemcitabine, albumin-bound paclitaxel or their excipients;
- Histopathologically-confirmed other pancreatic malignancies, such as pancreatic acinar cell carcinoma, pancreatic neuroendocrine tumor;
- Moderate-to-large pleural effusion, pericardial effusion or ascites with clinical symptoms, which requires frequent drainage (≥ 1 time per week) as judged by the investigator;
- History of organ transplantation (including autologous bone-marrow transplantation and peripheral stem-cell transplantation);
- Prior receipt of systemic anti-cancer 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 |
|---|---|---|
| Retlirafusp alfa Injectionetlirafusp alfa (1800 mg, q3w, Cycle 1)，until the disease or toxicity becomes intolerable (whichever comes first) | Drug | experimental group |
| FamitinibFamitinib (15mg, once daily, every 3 weeks),until the disease or toxicity becomes intolerable (whichever comes first). | Drug | experimental group |
| AGAlbumin-bound paclitaxel (125mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) combined with gemcitabine (1000mg/m² on days 1 and 8, every 3 weeks, for 6 cycles) until the disease progresses or toxicity becomes unbearable (whichever happens first). | Drug | experimental group |
Primary outcome
Progression-Free Survival
Time frame: From date of informed consent until date of first documented progression or death, assessed every 2 cycles (approximately 6 weeks) up to 2 years
5 secondary outcomes
Objective Response Rate
Time frame: From date of study entry up to 24 months.
Disease Control Rate
Time frame: From date of study entry up to 24 months.
Overall Survival
Time frame: From date of study entry (signing of informed consent) until death from any cause, assessed up to 24 months after the last patient enrolled.
AE
Time frame: From signing of informed consent until 90 days after the last dose of study treatment.
Objective Response Rate
Time frame: Objective Response Rate (ORR) defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1, assessed every 2 cycles (approximately 6 weeks) from start of treatment until disease progression
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 11 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.
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 Retlirafusp alfa Injection, Famitinib and AG in people with Pancreatic Cancer, run by The First Affiliated Hospital of Zhengzhou 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 11 inclusion and 20 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 11 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 Zhai Wenlong Chief Physician (13937150977, zhai-wl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From date of informed consent until date of first documented progression or death, assessed every 2 cycles (approximately 6 weeks) up to 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 11 Sep 2026.