Pancreatic CancerPhase 2NCT07773363
Retlirafusp Alfa Plus Apatinib and Chemotherapy as Second-Line Treatment for Pancreatic Cancer
A Phase 2 study testing Retlirafusp Alfa, Apatinib and Fluoropyrimidine-Based Chemotherapy in people with Pancreatic Cancer, run by Tang-Du Hospital.
Trial summary
This is a prospective, open-label, single-arm clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and chemotherapy as second-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer who have experienced disease progression after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Retlirafusp Alfa, Apatinib and Fluoropyrimidine-Based Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Dec 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
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic cancer.
- ECOG Performance Status of 0 or 1.
- Disease progression after first-line systemic therapy.
- At least one measurable lesion according to RECIST 1.1, as assessed by the investigator.
- Availability of 10 archived tumor tissue sections and 10 mL of peripheral blood.
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- Adequate organ function.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the end of study treatment. Male participants must also agree to use effective contraception during the study and for 6 months after the end of study treatment.
- Voluntary participation in the study, provision of written informed consent, and willingness and ability to comply with study procedures and follow-up.
Who cannot join
- Known hypersensitivity to the investigational drug or any of its excipients.
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks before study treatment.
- Participation in another investigational drug clinical study within 4 weeks before enrollment.
- History of other malignancy within the past 5 years, except for malignancies that have been definitively treated and are considered cured.
- Any of the following medical conditions: Untreated or symptomatic brain metastases or spinal cord compression. Other active malignancy requiring concurrent treatment.
- Active autoimmune disease or immunodeficiency, or a history of such conditions, including autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, or nephritis. Exceptions include stable conditions not requiring systemic immunosuppressive therapy, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin diseases not requiring systemic treatment, such as vitiligo, psoriasis, or alopecia. History of substance abuse or psychiatric disorders that may interfere with study participation.
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- Severe and/or uncontrolled medical conditions, including: Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg. Grade ≥1 myocardial ischemia or myocardial infarction; clinically significant arrhythmia, including QTc ≥450 ms in males or ≥470 ms in females; congestive heart failure of NYHA class ≥II; or LVEF <50%. Decompensated diabetes mellitus or other conditions contraindicating high-dose corticosteroid therapy. Exacerbation of chronic obstructive pulmonary disease (COPD) or other severe respiratory disease requiring hospitalization. Active or uncontrolled severe infection (≥Grade 2 according to CTCAE). Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment. Renal dysfunction with urine protein ≥++ on urinalysis and confirmed 24-hour urinary protein >1.0 g.
- Severe infection within 4 weeks before the first dose, including infectious complications, bacteremia, or severe pneumonia requiring hospitalization or intravenous antibiotics, antifungal agents, or antiviral therapy; or unexplained fever >38.5°C during screening or before the first dose.
- Active brain metastases or leptomeningeal metastases at enrollment.
- Acute pancreatitis meeting diagnostic criteria or subclinical pancreatitis requiring recent intervention.
- Any other condition that, in the investigator's judgment, may prevent the participant from complying with study procedures, restrictions, or requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-Label, Single-Arm Clinical Study of Retlirafusp Alfa Combined With Apatinib and Chemotherapy as Second-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
This is a prospective, open-label, single-arm clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and chemotherapy as second-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer who have experienced disease progression after first-line systemic therapy. Approximately 37 participants will be enrolled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety.
Read the detailed description
Pancreatic cancer is an aggressive malignancy with a poor prognosis. Most patients are diagnosed with unresectable locally advanced or metastatic disease, and treatment options after progression on first-line systemic therapy remain limited.
Pancreatic cancer is characterized by an immunosuppressive tumor microenvironment and dense desmoplastic stroma. TGF-β contributes to immune suppression and stromal remodeling, while PD-L1-mediated signaling promotes immune evasion. Retlirafusp alfa is a bifunctional fusion protein targeting PD-L1 and TGF-β receptor II (TGF-βRII), designed to simultaneously inhibit PD-L1/PD-1 signaling and TGF-β signaling.
This prospective, open-label, single-arm study will evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and fluoropyrimidine-based chemotherapy, with the specific chemotherapy regimen selected by the investigator, as second-line treatment for patients with unresectable locally advanced or metastatic pancreatic cancer after progression on first-line systemic therapy.
Approximately 37 participants will be enrolled. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other treatment discontinuation criteria are met. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety.
- Conditions
- Pancreatic Cancer
- Being tested
- Retlirafusp Alfa, Apatinib, Fluoropyrimidine-Based Chemotherapy
- Keywords
- Pancreatic Cancer, Retlirafusp Alfa, Apatinib, Second-Line Treatment
- 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 AlfaDrug
Retlirafusp alfa will be administered in combination with apatinib and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer.
ApatinibDrug
Apatinib will be administered in combination with retlirafusp alfa and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer.
Fluoropyrimidine-Based ChemotherapyDrug
Fluoropyrimidine-based chemotherapy selected at the investigator's discretion will be administered in combination with retlirafusp alfa and apatinib as second-line treatment for locally advanced or metastatic pancreatic cancer.
| Study group | Role | What they receive |
|---|---|---|
| Retlirafusp Alfa + Apatinib + Chemotherapy | Experimental | Participants will receive retlirafusp alfa combined with apatinib and fluoropyrimidine-based chemotherapy selected at the investigator's discretion as second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other criteria for treatment discontinuation are met. Receives: Drug: Retlirafusp Alfa; Drug: Apatinib; Drug: Fluoropyrimidine-Based Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) is defined as the time from the first administration of study treatment to the date of disease progression, as assessed by the investigator, or death from any cause, whichever occurs first.
Measured: Progression-free survival (PFS) will be assessed by the investigator according to RECIST 1.1, for up to 2 years after the first administration of study treatment.
Secondary outcomes (3)
Overall Survival
Overall survival (OS) is defined as the time from the first administration of study treatment to death from any cause.
Measured: Up to 3 years after the first administration of study treatment.
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.
Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years
Duration of Response
Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death.
Measured: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (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 Tang-Du HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773363
- Sponsor's protocol ID
- 20260625
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Clinical Study of Retlirafusp Alfa Combined With Apatinib and Chemotherapy as Second-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07773363
- Acronym / sponsor ID
- 20260625
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Retlirafusp Alfa, Apatinib, Second-Line Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 19 Aug 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 prospective, open-label, single-arm clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and chemotherapy as second-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer who have experienced disease progression after first-line systemic therapy. Approximately 37 participants will be enrolled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety.
Detailed description
Pancreatic cancer is an aggressive malignancy with a poor prognosis. Most patients are diagnosed with unresectable locally advanced or metastatic disease, and treatment options after progression on first-line systemic therapy remain limited.
Pancreatic cancer is characterized by an immunosuppressive tumor microenvironment and dense desmoplastic stroma. TGF-β contributes to immune suppression and stromal remodeling, while PD-L1-mediated signaling promotes immune evasion. Retlirafusp alfa is a bifunctional fusion protein targeting PD-L1 and TGF-β receptor II (TGF-βRII), designed to simultaneously inhibit PD-L1/PD-1 signaling and TGF-β signaling.
This prospective, open-label, single-arm study will evaluate the efficacy and safety of retlirafusp alfa combined with apatinib and fluoropyrimidine-based chemotherapy, with the specific chemotherapy regimen selected by the investigator, as second-line treatment for patients with unresectable locally advanced or metastatic pancreatic cancer after progression on first-line systemic therapy.
Approximately 37 participants will be enrolled. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other treatment discontinuation criteria are met. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retlirafusp Alfa + Apatinib + Chemotherapy | Experimental | Drug: Retlirafusp Alfa, Drug: Apatinib, Drug: Fluoropyrimidine-Based ChemotherapyParticipants will receive retlirafusp alfa combined with apatinib and fluoropyrimidine-based chemotherapy selected at the investigator's discretion as second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of informed consent, or other criteria for treatment discontinuation are met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years, male or female.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic cancer.
- ECOG Performance Status of 0 or 1.
- Disease progression after first-line systemic therapy.
- At least one measurable lesion according to RECIST 1.1, as assessed by the investigator.
Key exclusion criteria (11 listed)
- Known hypersensitivity to the investigational drug or any of its excipients.
- Major surgery, open biopsy, or significant traumatic injury within 4 weeks before study treatment.
- Participation in another investigational drug clinical study within 4 weeks before enrollment.
- History of other malignancy within the past 5 years, except for malignancies that have been definitively treated and are considered cured.
- Any of the following medical conditions: Untreated or symptomatic brain metastases or spinal cord compression. Other active malignancy requiring concurrent treatment.
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 AlfaRetlirafusp alfa will be administered in combination with apatinib and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer. | Drug | Retlirafusp Alfa + Apatinib + Chemotherapy |
| ApatinibApatinib will be administered in combination with retlirafusp alfa and fluoropyrimidine-based chemotherapy as second-line treatment for locally advanced or metastatic pancreatic cancer. | Drug | Retlirafusp Alfa + Apatinib + Chemotherapy |
| Fluoropyrimidine-Based ChemotherapyFluoropyrimidine-based chemotherapy selected at the investigator's discretion will be administered in combination with retlirafusp alfa and apatinib as second-line treatment for locally advanced or metastatic pancreatic cancer. | Drug | Retlirafusp Alfa + Apatinib + Chemotherapy |
Primary outcome
Progression-free survival
Time frame: Progression-free survival (PFS) will be assessed by the investigator according to RECIST 1.1, for up to 2 years after the first administration of study treatment.
Progression-free survival (PFS) is defined as the time from the first administration of study treatment to the date of disease progression, as assessed by the investigator, or death from any cause, whichever occurs first.
3 secondary outcomes
Overall Survival
Time frame: Up to 3 years after the first administration of study treatment.
Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years
Duration of Response
Time frame: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years.
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 19 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retlirafusp Alfa, Apatinib and Fluoropyrimidine-Based Chemotherapy in people with Pancreatic Cancer, run by Tang-Du Hospital.
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 11 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Min, Dr (13709202616, Minjie1504@163.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: Progression-free survival (PFS) will be assessed by the investigator according to RECIST 1.1, for up to 2 years after the first administration of study treatment.). 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 19 Aug 2026.