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Locally Advanced Pancreatic CancerPhase 1/2NCT07802184

GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC

A Phase 1/2 study testing SHR-1701, Apatinib and gemcitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-1701, Apatinib and gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
10 Sep 2026to 1 May 2029
Phase
Phase 1/2
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) Age 18-75 years, regardless of sex; 2) patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3) previously untreated patients with unresectable locally advanced or metastatic PDAC, with at least one measurable lesion according to RECIST v1.1, and target lesions must not have received prior radiotherapy or local treatment; 4) ECOG performance status of 0-1; 5) life expectancy ≥3 months; 6) willingness to comply with study procedures and able to receive treatment and undergo follow-up; 7) adequate major organ function, with laboratory test results meeting the following criteria within 7 days before enrollment: white blood cell (WBC) count ≥2.5×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet (PLT) count ≥75×10⁹/L, hemoglobin (HGB) ≥90 g/L (without blood transfusion or erythropoietin [EPO] dependence within 7 days), total bilirubin (TBIL) ≤1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN, albumin ≥30 g/L, international normalized ratio (INR) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN, and urinary protein ≤1+; 8) patients who are hepatitis B surface antigen (HBsAg)-positive with a peripheral blood hepatitis B virus DNA (HBV-DNA) level ≤1×10³/L; patients who are HBsAg-positive with a peripheral blood HBV-DNA level ≥1×10³/L may also be eligible if, in the investigator's judgment, chronic hepatitis B is clinically stable and does not increase the patient's risk; 9) voluntary participation in the study and provision of written informed consent.

Who cannot join

  • 1) Known hypersensitivity to any study drug; 2) known or suspected central nervous system metastases, defined as signs or symptoms suggestive of CNS metastasis, unless CNS metastasis has been excluded by CT or MRI; 3) history of other malignancies within 5 years, except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 4) requiring any concomitant anticancer treatment other than the study treatment during the study, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, or traditional Chinese medicine with antitumor activity; 5) prior or current treatment with chemotherapy, FAK inhibitors, or antibodies targeting PD-1, PD-L1, PD-L2, CD137, or cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), including ipilimumab or any other antibody or drug targeting T-cell costimulatory or checkpoint pathways; 6) diagnosis of immunodeficiency or chronic systemic corticosteroid therapy (prednisone >10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment; 7) receipt of a live vaccine within 30 days before the first dose of study treatment, including but not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated seasonal influenza vaccines are permitted, whereas live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not permitted; 8) uncontrolled hypertension, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment; 9) significant cardiac disease, including congestive heart failure (NYHA class III-IV), previous myocardial infarction, or uncontrolled angina within 6 months; 10) clinically significant arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, or ECG abnormalities confirmed on repeat examination that, in the investigator's judgment, require clinical intervention or treatment; 11) history of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor-related bleeding; 12) surgery required within 28 days before or anticipated within 28 days after the last dose of study treatment; 13) uncontrolled third-space fluid accumulation, such as large pleural effusion or ascites; 14) definite gastrointestinal bleeding tendency within 4 weeks before the first dose, including: ① active localized ulcerative lesions with positive fecal occult blood; ② melena or hematemesis within 28 days; or ③ positive fecal occult blood in patients with unresected tumor invasion of the gastrointestinal tract who, in the opinion of the principal investigator at the study center, may be at risk of major gastrointestinal bleeding; 15) previous gastrointestinal perforation or suspected risk of gastrointestinal perforation, or intestinal obstruction; 16) concomitant medications that, in the investigator's judgment, are required during the trial and may affect the metabolism of the investigational drug, such as strong CYP3A4 inhibitors or inducers, or drugs with a narrow therapeutic index that are primarily metabolized by CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2D6; 17) severe psychiatric disorders; 18) women who are pregnant, breastfeeding, or potentially pregnant; 19) women or men of childbearing potential unwilling to use effective contraception during the study and for 3 months after the last dose of study treatment; 20) participation in another clinical trial of a drug or medical device within 4 weeks before enrollment; 21) any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min Ren contact

China1 site
  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Dan Cao, +8618980605963, caodan@scu.edu.cn

Other trials in China

About this study

Official title: GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center, Open-Label, Phase Ib/II Trial

The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.

Read the detailed description

This study is a prospective, single-arm, single-center, phase Ib/II clinical trial evaluating the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.

Being tested
SHR-1701, Apatinib, gemcitabine, Nab-paclitaxel
Keywords
Locally advanced pancreatic cancer, Metastatic pancreatic cancer, SHR-1701, Apatinib, GnP
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1701Drug

    SHR-1701 is administered by intravenous infusion at a dose of 30 mg/kg once every 3 weeks (Q3W). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.

  • ApatinibDrug

    Apatinib is administered orally at a dose of 250 mg once daily (QD). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.

  • gemcitabineDrug

    Gemcitabine is administered by intravenous infusion at a dose of 1000 mg/m² on days 1 and 8 of each 3-week cycle.

  • Nab-paclitaxelDrug

    Nab-paclitaxel is administered by intravenous infusion at a dose of 125 mg/m² on days 1 and 8 of each 3-week cycle.

Study groups in NCT07802184
Study groupRoleWhat they receive
SHR-1701 combined with Apatinib and GnPExperimentalNot described
Receives: Drug: SHR-1701; Drug: Apatinib; Drug: gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase II Dose (RP2D)

    RP2D will be determined on the basis of evaluation on safety and efficacy data in Phase Ib.

    Measured: through phase I study completion, an average of 5 months

  2. Objective Response Rate (ORR)

    Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.

    Measured: through study completion, an average of 2 years

Secondary outcomes (8)
  1. Overall Survival (OS)

    Time from the first administration of study treatment to death from any cause. Participants who are alive or lost to follow-up at the time of analysis will be censored at the date of their last known survival assessment.

    Measured: through study completion, an average of 2 years

  2. Progression-Free Survival (PFS)

    Time from the first administration of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. Participants who are alive and have not experienced disease progression will be censored at the date of the last tumor assessment.

    Measured: through study completion, an average of 2 years

  3. Disease Control Rate (DCR)

    Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as the best overall response according to RECIST v1.1 criteria.

    Measured: through study completion, an average of 2 years

  4. Duration of Response (DOR)

    Time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: through study completion, an average of 2 years

  5. Time to Progression (TTP)

    Time from the first administration of study treatment to the first documented disease progression according to RECIST v1.1 in the ITT population. Participants who have not experienced disease progression at the time of analysis will be censored at the date of the last tumor assessment.

    Measured: through study completion, an average of 2 years

  6. R0 Resection Rate

    Proportion of participants in the ITT population who undergo surgical resection and achieve R0 resection, defined as complete macroscopic tumor removal with no microscopic residual tumor at the resection margin.

    Measured: through study completion, an average of 2 years

  7. Incidence of Treatment-Related Adverse Events (TRAEs)

    Incidence and severity of adverse events considered by the investigator to be related to study treatment, graded according to NCI-CTCAE version 5.0.

    Measured: through study completion, an average of 2 years

  8. Incidence of Serious Adverse Events (SAEs)

    Incidence of serious adverse events, including events resulting in death, life-threatening events, hospitalization or prolongation of hospitalization, persistent or significant disability, congenital anomaly, or other medically important events.

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start10 Sep 2026 (estimated)
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07802184
Sponsor's protocol ID
SHR1701-IIT-PDAC001
Status last verified
Sep 2026
First submitted
26 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1701, Apatinib and gemcitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by West China Hospital 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 1 inclusion and 1 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 3 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Dan Cao (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) (time frame: through phase I study completion, an average of 5 months). 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 3 Sep 2026.

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