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Gastric AdenocarcinomaPhase 2NCT06667050

CAPOX Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric Cancer

A Phase 2 study testing Chemotherapy plus sintilimab and bevacizumab in people with Gastric Adenocarcinoma, run by West China Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Neoadjuvant chemotherapy has been recommended by a series of treatment guidelines for the neoadjuvant treatment of locally advanced G/GEJ cancer. Although with clinical efficacy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Chemotherapy plus sintilimab and bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
10 Oct 2024to 31 Oct 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.
  • Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT3N+/T4aNany M0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
  • Resectable G/GEJ cancer, as judged by experienced surgeons.
  • There was no previous antitumor treatment.
  • The expected survival is more than 3 months.
  • ECOG PS≤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 ≥ 100,000 /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 drug clinical trials or having participated in any drug clinical trials one month before enrollment.
  • Active autoimmune disease or history of refractory autoimmune disease.
  • 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.
  • Active or clinically significant cardiac disease:
  • Congestive heart failure > New York Heart Association (NYHA) class 2;
  • Active coronary artery disease;
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  • 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
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Grade 3 bleeding events 4 weeks before enrollment.
  • Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
  • Currently taking anticoagulants.
  • Gastrointestinal perforation, gastrointestinal obstruction, or uncontrollable diarrhea 6 months before 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 pheochromocytoma.
  • 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 pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade).
  • History of organ transplantation (including corneal transplantation).
  • Allergic 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 oxaliplatin, capecitabine, ICIs and anti-angiogenesis drugs;
  • Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage).
  • Treatment with antitumor Chinese herbal medicine.
  • History of allogeneic blood transfusion within 6 months.
  • Vaccination history within 4 weeks before enrollment.
  • The investigator believes that patients who are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: CAPOX Combined with Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Prospective, Multi-center, Single-arm, Phase II Clinical Trial

Neoadjuvant chemotherapy has been recommended by a series of treatment guidelines for the neoadjuvant treatment of locally advanced G/GEJ cancer. Although with clinical efficacy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with sintilimab and bevacizumab biosimilar (IBI305) in the neoadjuvant treatment for locally advanced G/GEJ cancer.

Read the detailed description

This is a prospective, multicenter, single-arm, phase II trial. A total of 58 patients will be enrolled. Eligible patients will be registered and receive three cycles of CAPOX plus sintilimab and bevacizumab biosimilar (IBI305) regimen. Radical D2 gastric cancer resection will be performed 6-8 weeks after the last administration of chemotherapy plus plus sintilimab and bevacizumab biosimilar (IBI305). The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS) and safety profile of the neoadjuvant regimen.

Being tested
Chemotherapy plus sintilimab and bevacizumab

What participants receive

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

  • Chemotherapy plus sintilimab and bevacizumabDrug

    Laparoscopic exploration should be performed to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum.

    3 cycles of neoadjuvant therapy will be administered: capecitabine: 100 mg/m2, Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; sintilimab: 200 mg, iv drip, d1, bevacizumab biosimilar (IBI305) 10mg

    /Kg, iv drip, d1, q3w. Radical D2 gastric cancer resection will be performed within 6-8 weeks after the last administration of chemotherapy plus sintilimab and bevacizumab biosimilar (IBI305).

    The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with CAPOX regimen for up to 3 cycles.

Study groups in NCT06667050
Study groupRoleWhat they receive
chemotherapy plus sintilimab and bevacizumab biosimilarExperimentalcapecitabine: 100 mg/m2, Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; sintilimab: 200 mg, iv drip, d1, bevacizumab biosimilar (IBI305) 10mg /Kg, iv drip, d1, q3w.
Receives: Drug: Chemotherapy plus sintilimab and bevacizumab

What is being measured

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

  1. pCR rate

    defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy

    Measured: 6 months after the last subject participating in

Secondary outcomes (5)

  1. R0 resection rate

    defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed

    Measured: 6 months after the last subject participating in

  2. MPR rate

    defined as tumor residual cells ≤10% in the surgical specimen

    Measured: 6 months after the last subject participating in

  3. Event-free survival

    defined as the time from randomization to occurrence of a major adverse clinical event, such as failure to achieve remission, relapse, and death during remission.

    Measured: 2 years after the last subject participating in

  4. Overall survival

    defined as the time from randomization to occurrence of death during remission.

    Measured: 2 years after the last subject participating in

  5. Treatment-related adverse events

    Treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 3 months after the last administration of drugs

Timeline

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

  1. First posted31 Oct 2024
  2. Study start10 Oct 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 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
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667050
Sponsor's protocol ID
WCH241260
Status last verified
Oct 2024
First submitted
27 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy plus sintilimab and bevacizumab in people with Gastric Adenocarcinoma, 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 18 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 31 Oct 2024. 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?

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?

pCR rate (time frame: 6 months after the last subject participating in). 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 NCT06667050.

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 31 Oct 2024.

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