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Gastric AdenocarcinomaPhase 2NCT07709767

Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Retlirafusp Alfa, Oxaliplatin and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Tang-Du Hospital.

Not yet recruiting

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

Official record
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Trial summary

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Retlirafusp Alfa, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
30 Aug 2026to 30 Aug 2032
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

  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by gastroscopic biopsy.
  • Potentially resectable gastric or gastroesophageal junction adenocarcinoma as judged by the investigator, including but not limited to: T4b disease or fixed/fused lymph nodes; single liver metastasis, limited para-aortic lymph node metastasis (No.16a2/b1), or CY1P0 disease; more than one liver metastasis or a liver metastasis larger than 5 cm adjacent to the hepatic vein or portal vein, extensive para-aortic lymph node metastasis (No.16a1/b2), or selected distant metastases such as Virchow lymph node or lung metastasis.
  • HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1.
  • Age 18 to 75 years.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • No prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
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  • Adequate organ function, defined as: white blood cell count ≥3.0 × 10^9/L; absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; total bilirubin ≤ upper limit of normal; AST and ALT ≤3 × upper limit of normal; serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥50 mL/min; activated partial thromboplastin time and international normalized ratio ≤1.5 × upper limit of normal; cardiac enzymes within normal range; and normal thyroid function. Participants with abnormal baseline TSH may be eligible if total T3 or free T3 and free T4 are within the normal range.
  • Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and agree to use effective contraception during the study and for at least 3 months after the last dose. Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for at least 3 months after the last dose.
  • Good compliance and willingness to complete study follow-up.

Who cannot join

  • History of malignancy within 5 years or current presence of another malignancy.
  • Prior systemic therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Macroscopically visible peritoneal metastasis or other unresectable distant metastasis.
  • Active bleeding from the tumor as shown by endoscopy.
  • Use of traditional Chinese medicine with antitumor indication or systemic immunomodulatory drugs, including thymosin, interferon, or interleukin, within 2 weeks before the first dose, except for local use to control pleural effusion.
  • Requirement for systemic corticosteroids equivalent to prednisone >10 mg/day or other immunosuppressive therapy within 14 days before the first dose or during the study, except for topical or inhaled corticosteroids or adrenal replacement therapy at a dose equivalent to prednisone ≤10 mg/day in the absence of active autoimmune disease.
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  • Any active infection requiring systemic anti-infective therapy within 14 days before the first dose, except prophylactic antibiotics.
  • Thrombotic events within 6 months before screening, including cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or pulmonary embolism, except catheter-related venous thrombosis that has resolved as judged by the investigator.
  • Myocardial infarction or poorly controlled arrhythmia within 6 months before the first dose, including QTc interval ≥450 ms in males or ≥470 ms in females using Fridericia's formula.
  • New York Heart Association class III or IV heart failure or left ventricular ejection fraction <50% by echocardiography.
  • Known hypersensitivity to SHR-1701 or active ingredients or excipients of the chemotherapy drugs used in this study.
  • Known history of human immunodeficiency virus infection.
  • Untreated active hepatitis B, defined as HBsAg positivity with HBV DNA above the upper limit of normal at the study site.
  • Receipt of a live vaccine within 30 days before the first dose.
  • Active pulmonary tuberculosis.
  • Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
  • Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.
  • Poorly controlled diabetes mellitus, defined as fasting blood glucose >10 mmol/L.
  • Any medical history, disease, treatment, laboratory abnormality, or other condition that may interfere with study results, prevent full participation in the study, or pose additional risk as judged by the investigator.

About this study

Official title: A Single-Arm, Exploratory Study of Retlirafusp Alfa Plus Chemotherapy as Conversion Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.

Read the detailed description

Eligible patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma will receive retlirafusp alfa plus CAPOX every 3 weeks for 4 to 6 cycles before surgery. Tumor response will be assessed according to RECIST version 1.1. Patients with complete response or partial response who are considered suitable for R0 resection by a multidisciplinary team will undergo radical surgery 4 to 6 weeks after the last dose of preoperative treatment. Postoperative retlirafusp alfa maintenance therapy is recommended for up to 2 years. Patients who do not meet surgical criteria will receive subsequent treatment at the investigator's discretion. Efficacy outcomes include R0 resection rate, conversion surgery rate, event-free survival, objective response rate, and overall survival. Safety will be assessed according to CTCAE version 5.0 and perioperative complications will be graded using the Clavien-Dindo classification.

Being tested
Retlirafusp Alfa, Oxaliplatin, Capecitabine, Radical Surgery
Keywords
Retlirafusp Alfa, SHR-1701, CAPOX, Conversion Therapy, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, R0 Resection
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Retlirafusp AlfaDrug

    Retlirafusp alfa 1800 mg will be administered by intravenous infusion on Day 1 of each 21-day cycle. When administered with chemotherapy, retlirafusp alfa will be given first, followed by chemotherapy after an interval of at least 30 minutes.

  • OxaliplatinDrug

    Oxaliplatin 130 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

  • CapecitabineDrug

    Capecitabine 1000 mg/m^2 will be administered orally twice daily on Days 1-14 of each 21-day cycle.

    Interventi

  • Radical SurgeryProcedure or surgery

    Participants who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery 4 to 6 weeks after the last dose of preoperative treatment.

Study groups in NCT07709767
Study groupRoleWhat they receive
Retlirafusp Alfa Plus CAPOXExperimentalNot described
Receives: Drug: Retlirafusp Alfa; Drug: Oxaliplatin; Drug: Capecitabine; Procedure: Radical Surgery

What is being measured

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

  1. R0 Resection Rate

    The proportion of enrolled participants who undergo radical surgery with microscopically margin-negative resection. R0 resection will be assessed based on postoperative pathological evaluation.

    Measured: From treatment initiation to pathological assessment after radical surgery, up to approximately 28 weeks

Secondary outcomes (6)

  1. Conversion Surgery Rate

    The proportion of enrolled participants who undergo radical surgery after preoperative conversion therapy and multidisciplinary team assessment.

    Measured: From treatment initiation to radical surgery, up to approximately 24 weeks

  2. Event-Free Survival

    Event-free survival is defined as the time from initiation of treatment to the first occurrence of radiographic disease progression according to RECIST version 1.1, tumor recurrence confirmed by imaging or biopsy, or death from any cause, whichever occurs first.

    Measured: From treatment initiation to disease progression, recurrence, or death from any cause, assessed up to approximately 32 months

  3. Objective Response Rate

    Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1.

    Measured: From baseline to preoperative tumor assessment after completion of preoperative conversion therapy, up to approximately 20 weeks

  4. Overall Survival

    Overall survival is defined as the time from treatment initiation to death from any cause.

    Measured: From treatment initiation to death from any cause, assessed up to approximately 32 months

  5. Incidence of Treatment-Related Adverse Events

    Treatment-related adverse events, grade 3 or higher treatment-related adverse events, and immune-related adverse events will be assessed according to CTCAE version 5.0.

    Measured: From treatment initiation to 30 days after the last dose of study treatment

  6. Incidence of Perioperative Complications

    Perioperative complications will be assessed using the Clavien-Dindo classification.

    Measured: From radical surgery to 30 days after radical surgery

Timeline

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

  1. First posted17 Jul 2026
  2. Study start30 Aug 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Aug 2032 (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
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709767
Sponsor's protocol ID
K202606-54
Status last verified
Jul 2026
First submitted
9 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified individual participant data will not be shared because this is a single-center investigator-initiated exploratory study, and the informed consent and data governance arrangements do not currently include a plan for sharing participant-level data with external researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retlirafusp Alfa, Oxaliplatin and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, 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 19 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 17 Jul 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: From treatment initiation to pathological assessment after radical surgery, up to approximately 28 weeks). 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 NCT07709767.

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 17 Jul 2026.

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