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Gastric Cancer Adenocarcinoma MetastaticPhase 2NCT07392346

Safety and Efficacy of Fruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection in the Second-Line Treatment for Immunotherapy-experienced Advanced Gastric Cancer

A Phase 2 study testing Fruquintinib, Iparomlimab and Tuvonralimab and Paclitaxel (albumin-bound) in people with Gastric Cancer Adenocarcinoma Metastatic, run by Dai, Guanghai at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer Adenocarcinoma Metastatic
What is being tested?
Fruquintinib, Iparomlimab and Tuvonralimab and Paclitaxel (albumin-bound)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
1 Dec 2025to 30 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years
  • Pathologically or cytologically confirmed diagnosis of gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.
  • Failure of first-line treatment with PD-1/PD-L1 inhibitors
  • With measurable lesions according to RECIST 1.1 criteria.
  • ECOG performance status of 0-1
  • Expected survival ≥3 months;
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  • Major organ functions meet the following requirements :
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L) (no growth factors used within 14 days).
  • Platelet count (PLT) ≥ 100,000/mm³ (100 × 10⁹/L) (no correction therapy used within 7 days).
  • Hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no correction therapy used within 7 days).
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
  • Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN).
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 2.5 × upper limit of normal (ULN); ≤ 5 × upper limit of normal (ULN) for patients with liver metastases.
  • Urinalysis is normal, or urine protein < (++), or 24-hour urine protein level < 1.0 g.
  • Normal coagulation function, with no history of active bleeding or thrombotic diseases:
  • International normalized ratio (INR) ≤ 1.5 × ULN.
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • Prothrombin time (PT) ≤ 1.5 × ULN.
  • For patients with potential fertility, the following requirements must be met:
  • Adopt a medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 3 months after the completion of study treatment.
  • Serum human chorionic gonadotropin (β-HCG) test must be negative within 72 hours prior to study enrollment.
  • Must not be breastfeeding.
  • Patients must have provided written informed consent, and be willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other trial procedures.

Who cannot join

  • History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of study medication.
  • Uncontrolled pleural, pericardial, or peritoneal effusions requiring repeated drainage.
  • Hypersensitivity to any component of monoclonal antibodies, fruquintinib, or albumin-bound paclitaxel.
  • Receipt of any of the following treatments:
  • Severe adverse reactions to prior immunotherapy.
  • Prior treatment with CTLA4 inhibitors.
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  • Any study medication within 4 weeks prior to the first dose of study medication.
  • Concurrent enrollment in another clinical study (excluding observational studies or survival follow-ups of interventional studies).
  • Last dose of anti-cancer therapy ≤ 3 weeks prior to the first study medication, or fixed-field palliative radiotherapy ≤ 2 weeks prior to study intervention.
  • Corticosteroid use (>10 mg prednisone equivalent/day) within 2 weeks prior to study medication; the investigator may decide on eligibility in special cases. Inhaled/topical steroids and adrenal replacement at >10 mg/day prednisone equivalent are permitted in the absence of active autoimmune diseases.
  • Anti-tumor vaccines or live vaccines within 4 weeks prior to study medication.
  • Major surgery or severe trauma within 4 weeks prior to study medication.
  • Previous anti-tumor treatment toxicities not recovered to ≤ CTCAE Grade 1 (excluding alopecia) or the specified inclusion/exclusion criteria levels.
  • Central nervous system metastases.
  • History of active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or a history of such diseases (excluding vitiligo, or childhood asthma/allergies cured and requiring no intervention in adulthood; autoimmune hypothyroidism on stable thyroid replacement; type 1 diabetes on stable insulin).
  • Immunodeficiency history (including HIV-positive status, acquired/congenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation).
  • Inadequately controlled cardiovascular symptoms/diseases, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular/ventricular arrhythmias (uncontrolled with clinical intervention).
  • Urinalysis showing urine protein ≥++ and confirmed 24-hour urine protein >1.0 g.
  • Abnormal coagulation (INR >1.5×ULN or PT >ULN+4s), with bleeding tendency or thrombolytic/anticoagulant therapy (small-dose low-molecular-weight heparin or oral aspirin for prophylaxis permitted during the trial).
  • Significant clinical bleeding or definite bleeding tendency within 3 months (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis). If baseline occult blood in stool is positive, re-testing is allowed; endoscopy may be performed based on clinical judgment if positive after re-testing.
  • Active ulcers, unhealed wounds, or fractures.
  • Hypertension inadequately controlled by anti-hypertensive medication (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg).
  • Severe infection (CTCAE >Grade 2) within 4 weeks prior to study medication (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization); baseline chest imaging showing active pulmonary inflammation, or infection symptoms/signs requiring oral/IV antibiotics within 2 weeks prior to study medication (excluding prophylactic antibiotics).
  • History of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonitis not treated with steroids).
  • Active tuberculosis (confirmed by history/CT) or history of active tuberculosis within 1 year prior to enrollment, or untreated active tuberculosis more than 1 year prior to enrollment.
  • History of any other malignant tumor within 5 years prior to study medication (excluding low-risk tumors with >90% 5-year survival rate, e.g., adequately treated basal cell/squamous cell skin cancer or cervical intraepithelial neoplasia).
  • Pregnant or breastfeeding women.
  • Other factors (e.g., concurrent severe diseases including mental illness, severely abnormal lab values, family/social factors) that may lead to forced withdrawal from the study, as determined by the investigator.

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

  • Chinese PLA General Hospital, Beijing

    Beijing, Beijing Municipality

    Guanghai Dai, M.D., 01066947252, daigh301@vip.sina.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Phase Ⅱ Clinical Trial Evaluating Fruquintinib in Combination With Paclitaxel for Injection (Albumin-bound) and Iparomlimab and Tuvonralimab Injection as Second-Line Therapy in Advanced Gastric Cancer Patients Previously Received Immunotherapy

Immunotherapy has established the new standard for first-line treatment of advanced or metastatic gastric cancer. However, current second-line options-predominantly consisting of targeted therapy plus chemotherapy or chemotherapy alone-confer only modest clinical benefit. Notably, pivotal phase III second-line trials (REGARD, RAINBOW, RAINBOW-Asia, FRUTIGA) exclusively enrolled patients who progressed on chemotherapy regimens; thus, high-quality evidence guiding second-line treatment specifically for immunotherapy-refractory patients remains scarce, representing a significant unmet medical need.

Anti-angiogenic agents have demonstrated capacity to ameliorate the hypoxic, immunosuppressive tumor microenvironment while exerting synergistic anti-tumor effects when combined with immune checkpoint inhibitors. Exploratory studies evaluating immunotherapy combined with anti-angiogenic therapy plus chemotherapy in advanced gastric cancer patients after first-line failure have yielded encouraging efficacy signals (NCT03966118, NCT04982276), with objective response rates of 30-40% and median progression-free survival approaching 6 months.

Based on this, the investigators aim to evaluate the efficacy and safety profile of fruquintinib combined with nab-paclitaxel and Iparomlimab and Tuvonralimab Injection (a novel bispecific antibody) as second-line treatment for patients with advanced gastric cancer who have experienced disease progression during or after first-line immunotherapy-containing regimens.

Being tested
Fruquintinib, Iparomlimab and Tuvonralimab, Paclitaxel (albumin-bound)

What participants receive

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

  • FruquintinibDrug

    3 mg qd, po, q3W; After 6 cycles of combination therapy, maintenance treatment consisting of Iparomlimab and Tuvonralimab Injection plus Fruquintinib will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or investigator's determination that the subject should discontinue from study treatment.

  • Iparomlimab and TuvonralimabDrug

    5.0 mg/kg, Day 1, q3W, iv. After 6 cycles of combination therapy, maintenance treatment consisting of Iparomlimab and Tuvonralimab Injection plus Fruquintinib will continue until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, or investigator's determination that the subject should discontinue from study treatment.

  • Paclitaxel (albumin-bound)Drug

    250 mg/m², Day 1, q3W

Study groups in NCT07392346
Study groupRoleWhat they receive
Study armExperimentalFruquintinib Plus Nab-Paclitaxel and Iparomlimab and Tuvonralimab Injection are administered until disease progression or toxicity intolerable.
Receives: Drug: Fruquintinib; Drug: Iparomlimab and Tuvonralimab; Drug: Paclitaxel (albumin-bound)

What is being measured

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

  1. Progress-free Survival(PFS)

    The time from enrollment until tumor progression or death from any cause, whichever occurred first

    Measured: 24 months

Secondary outcomes (3)

  1. Objective response rate (ORR)

    The proportion of patients with a confirmed complete response or partial response

    Measured: 24 months

  2. Disease control rate (DCR)

    The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease

    Measured: 24 months

  3. Overall Survival (OS)

    The time from randomization to death from any reason

    Measured: 24 months

Timeline

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

  1. First posted6 Feb 2026
  2. Study start1 Dec 2025
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392346
Sponsor's protocol ID
2026-003
Status last verified
Feb 2026
First submitted
30 Jan 2026
Last updated
11 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib, Iparomlimab and Tuvonralimab and Paclitaxel (albumin-bound) in people with Gastric Cancer Adenocarcinoma Metastatic, run by Dai, Guanghai 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 23 inclusion and 28 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 11 Feb 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free Survival(PFS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07392346.

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 Feb 2026.

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