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Gastric CancerPhase 2NCT06349967

Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer

A Phase 2 study testing Nab-paclitaxel Combined With Cadonilimab (AK104) in people with Gastric Cancer, run by West China Hospital.

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

Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. 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?
Nab-paclitaxel Combined With Cadonilimab (AK104)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
No sites listed yet
Study dates
30 Apr 2024to 30 May 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

  • Age 18-75 years.
  • Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological/cytological examination.
  • No previous antitumor treatment.
  • Agree to provide blood/tissue specimens.
  • The expected survival is longer than 3 months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status≤1.
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  • Adequate organ function including the following:
  • Total bilirubin ≤1.5 times the upper limit of normal (ULN);
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
  • Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
  • Serum creatinine≤1.5×ULN;
  • Serum amylase and lipase≤1.5×ULN;
  • International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
  • Platelet count ≥ 75,000 /mm3;
  • Hemoglobin (Hb) ≥ 9 g/dL;
  • Absolute neutrophil count (ANC) ≥ 1500/mm3;
  • Strict contraception.
  • Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Who cannot join

  • Undergoing other clinical trials or having participated in any drug clinical trials one month before enrollment.
  • Hyperprogression occurs in first-line immunotherapy: (1) Tumor burden increased more than 50% compared to baseline upon the first assessment (2-4 cycles of first-line treatment); (2) Tumor growth rate exceeded the previous rate by more than twice after immunotherapy.
  • Active autoimmune disease or history of refractory autoimmune disease.
  • Grade 3-4 immune hepatitis, immune pneumonia, immune myocarditis, etc. appear in first-line immunotherapy.
  • Receiving corticosteroids (>10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
  • HER2 positive patients who did not receive trastuzumab in first-line treatment.
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  • Active or clinically significant cardiac disease:
  • Congestive heart failure > New York Heart Association (NYHA) class 2;
  • Active coronary artery disease;
  • Arrhythmias requiring treatment other than β-blockers or digoxin;
  • Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment.
  • Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6 months prior to enrollment.
  • Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
  • Patients with a history of HIV infection or active hepatitis B/C.
  • Ongoing > level 2 infection.
  • Symptomatic brain metastasis or meningioma.
  • Unhealed wounds, ulcers or fractures.
  • Renal failure patients requiring blood or peritoneal dialysis.
  • Epileptic that needs medication.
  • Active, symptomatic interstitial lung disease, pleural effusion or ascites that causes breathing difficulties (≥ grade 2 breathing difficulties).
  • History of organ transplantation (including corneal transplantation).
  • Allergy to research drugs or similar drugs, or suspected allergies.
  • Pregnant or lactating women.
  • Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results.
  • Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
  • Previously used similar chemotherapy drugs or immune checkpoint inhibitors;
  • Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery.
  • Treatment with antitumor Chinese herbal medicine.
  • Vaccination history 4 weeks prior to enrollment
  • The investigator believes that patients who are not suitable for the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pengfei Zhang, M.D contact

+86-17828163584

fly_121988@126.com

About this study

Official title: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer: A Prospective, Multicenter, Single-arm, Phase II Study

Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer.

Read the detailed description

This trial is a prospective, multicenter, single arm, phase II clinical study. It is divided into three stages: screening period, treatment period, and follow-up period. The main research objective of this study is to evaluate the objective response rate (ORR) of albumin paclitaxel combined with kandelizumab (AK104) in second-line treatment of gastric cancer with failed first-line fluorouracil/platinum combination immunotherapy. Secondary study objective: To evaluate the disease control rate (DCR), progression free survival (PFS), overall survival (OS), safety, tolerability, and impact on patient quality of life (QoL) of albumin paclitaxel combined with candelizumab (AK104) in second-line treatment of gastric cancer with failed first-line fluorouracil/platinum immunotherapy.

Conditions
Gastric Cancer
Being tested
Nab-paclitaxel Combined With Cadonilimab (AK104)
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Nab-paclitaxel Combined With Cadonilimab (AK104)Drug

    Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;

Study groups in NCT06349967
Study groupRoleWhat they receive
Nab-paclitaxel+Cadonilimab (AK104)ExperimentalNab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;
Receives: Drug: Nab-paclitaxel Combined With Cadonilimab (AK104)

What is being measured

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

  1. overall response rate (ORR)

    the proportion of patients with the best overall response of complete response (CR) or partial response (PR)

    Measured: every 3 month postoperation up to 24 months

Secondary outcomes (3)

  1. disease control rate (DCR)

    the proportion of patients with the best overall response of CR or PR or stable disease (SD)

    Measured: every 3 month postoperation up to 24 months

  2. overall survival (OS)

    defined as the time from randomization to death

    Measured: every 3 month postoperation up to 24 months

  3. progression-free survival (PFS)

    defined as the time from randomization to disease progression

    Measured: every 3 month postoperation up to 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 posted5 Apr 2024
  2. Study start30 Apr 2024 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 May 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
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349967
Sponsor's protocol ID
WCH-2023-1592
Status last verified
Mar 2024
First submitted
31 Mar 2024
Last updated
5 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wei J, Zhang P, Hu Q, Cheng X, Shen C, Chen Z, Zhuang W, Yin Y, Zhang B, Gou H, Yang K, Bi F, Liu M. Nab-paclitaxel combined with cadonilimab (AK104) as second-line treatment for advanced gastric cancer: protocol for a phase II prospective, multicenter, single-arm clinical trial. Front Immunol. 2025 Feb 25;16:1519545. doi: 10.3389/fimmu.2025.1519545. eCollection 2025.

    PubMed 40070819

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel Combined With Cadonilimab (AK104) in people with Gastric Cancer, run by West China 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 18 inclusion and 30 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 5 Apr 2024. 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 Pengfei Zhang, M.D (+86-17828163584, fly_121988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate (ORR) (time frame: every 3 month postoperation up to 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 NCT06349967, which also lists 1 linked publication.

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 5 Apr 2024.

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