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Gastric CancerPhase 2NCT06791148

Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer

A Phase 2 study testing Low-dose radiotherapy, albumin-bound paclitaxel and AK112 in people with Gastric Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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
Search all trials

Trial summary

The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
Low-dose radiotherapy, albumin-bound paclitaxel and AK112
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
10 Jul 2024to 10 Dec 2027
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

  • Sign the informed consent form.
  • ≥18 years and ≤75 years .
  • Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (AJCC 8.0);failed first-line standard treatment.
  • PS 0-2.
  • Expected survival ≥ 6 months.
  • With at least one measurable lesion (RECIST 1.1 criteria) in the subject .
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  • Within 7 days before starting study treatment, no blood components or growth factors have been used, and Adequate organ function is determined by the following criteria:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L;Platelets ≥ 90 x 10^9/L
  • ;Hemoglobin ≥ 80 g/L;Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 ml/min; Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN Cardiac enzyme levels within normal range (minor lab abnormalities deemed not clinically significant by the investigator are allowed)
  • For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first dose of study drug. If the urine test is inconclusive, a blood pregnancy test is required. Postmenopausal women are defined as those who have had no menses for at least 1 year or have undergone surgical sterilization or hysterectomy.
  • All participants with fertility potential must use contraception with a failure rate <1% during treatment and for 120 days after the last dose of study drug (or 180 days after the last chemotherapy dose), regardless of gender.

Who cannot join

  • Diagnosis of any malignancy other than gastric cancer within 5 years before the first dose (excluding cured basal cell or squamous cell skin cancers and/or carcinoma in situ treated with curative intent).
  • Imaging during screening shows tumors encasing major blood vessels or with significant necrosis/cavitation, posing a bleeding risk as determined by the investigator.
  • Currently participating in another interventional clinical study or received other investigational drugs or devices within 4 weeks before the first dose.
  • Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments.
  • Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study.
  • Known history of allogeneic organ transplantation (excluding corneal transplants) or allogeneic hematopoietic stem cell transplantation.
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  • Known allergy to any drug used in this study.
  • Not fully recovered from toxicity and/or complications of any prior interventions before starting treatment (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia).
  • Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies).
  • Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA levels above the upper limit of normal at the study center).
  • Active HCV infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection).
  • Received live vaccines within 30 days before the first dose (Day 1, Cycle 1). Note: Inactivated seasonal influenza vaccines administered by injection are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccines are not permitted.
  • Pregnant or breastfeeding women.
  • Presence of any severe or uncontrolled systemic diseases, including:
  • Significant and symptomatic ECG abnormalities at rest that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.
  • Unstable angina, congestive heart failure, or chronic heart failure classified as NYHA ≥ Grade 2.
  • Any arterial thrombosis, embolism, or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
  • Suboptimal blood pressure control (systolic BP > 150 mmHg, diastolic BP > 100 mmHg).
  • History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year before the first dose, or current clinically active interstitial lung disease.
  • Active tuberculosis.
  • Any active or uncontrolled infection requiring systemic treatment.
  • Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
  • Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
  • Poorly controlled diabetes (fasting blood glucose > 10 mmol/L).
  • Any condition, illness, treatment, or abnormal laboratory value that could interfere with trial results, hinder the participant's full involvement in the study, or pose additional risks, as determined by the investigator. This includes any situation deemed unsuitable for enrollment 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.

Jia Wei, MD contact

0086-025-83304616

jiawei99@nju.edu.cn

China1 site, 1 recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

    Jia Wei, MD, 0086-025-83304616

    Recruiting

Other trials in China

About this study

Official title: Low-dose Radiotherapy Combined With Albumin-bound Paclitaxel and AK112 as Second-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction（G.GEJ）Cancer Who Failed First-line Therapy：a Single，Phase II Trial

The study aims to evaluate the efficacy and safety of the combination of albumin-bound paclitaxel and AK112 with low-dose radiotherapy in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.

Conditions
Gastric Cancer
Being tested
Low-dose radiotherapy, albumin-bound paclitaxel, AK112
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Low-dose radiotherapyRadiation

    2Gy/f，q3w，×4f

  • albumin-bound paclitaxelDrug

    100-120mg/m2,i.v.,d2,d9,q3w

  • AK112Drug

    20mg/kg, i.v., d2, q3w

Study groups in NCT06791148
Study groupRoleWhat they receive
low-dose radiotherapy plus chemo and AK112ExperimentalRadiation therapy for metastatic lesions: Radiation therapy begins within 24 hours before medication administration, with a dose of 2Gy per fraction, administered once every three weeks, for a total of four fractions. Chemo：albumin-bound paclitaxel ，100-120mg/m2,i.v.,d2,d9,q3w； AK112：20mg/kg, i.v., d2, q3w
Receives: Radiation: Low-dose radiotherapy; Drug: albumin-bound paclitaxel; Drug: AK112

What is being measured

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

  1. Progression-free survival (PFS)

    Refers to the date from the date of admission to the date of the first progression of disease or death of any cause, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Measured: up to 24 months

  2. AE

    Number and percentage of participants with Adverse Events(any grade)

    Measured: up to 24 months after enrollment or study close

Secondary outcomes (3)

  1. Overall survival (OS)

    The time interval between the start date of study drug and the date of death (any cause)

    Measured: up to 3 years

  2. Duration of Response(DoR)

    monitor the length of time patients experience a reduction in tumor size or stabilization of disease following the treatment

    Measured: up to 12 months

  3. Disease control rate (DCR)

    Disease control rate (DCR)

    Measured: up to 12 months

Timeline

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

  1. First posted24 Jan 2025
  2. Study start10 Jul 2024
  3. Primary completion10 Jul 2027 (estimated)
  4. Study completion10 Dec 2027 (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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06791148
Sponsor's protocol ID
AK112-IIT-C-M-0003
Status last verified
Jan 2025
First submitted
18 Jan 2025
Last updated
24 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-dose radiotherapy, albumin-bound paclitaxel and AK112 in people with Gastric Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 25 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 24 Jan 2025. 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 Jia Wei, MD (0086-025-83304616, jiawei99@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 24 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?

On the ClinicalTrials.gov record for NCT06791148.

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 24 Jan 2025.

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