Badanie denikitug jako monoterapia lub w połączeniu (kombinacja leków) u dorosłych z przerzutowym HER2‑negatywnym rakiem żołądka, przełyku i przyłącza przełykowo‑żołądkowego

Baseline assessments

After joining the study you will attend a baseline visit where a medical history, physical Examination, laboratory tests and imaging studies are performed to document the current status of the disease.

The purpose of these assessments is to establish a reference point for later comparisons.

Randomization to treatment arm

Based on the study design you will be assigned to one of three possible treatment groups: denikitug alone, denikitug together with nivolumab, or denikitug together with ramucirumab and paclitaxel.

The assignment is made by the study team using a random process and you will be informed of the Group to which you have been allocated.

Initiation of study medication

The first infusion of the assigned medication(s) is given intravenously (i.v.), which means the drug is delivered directly into a vein.

If you are in the denikitug monotherapy arm, only denikitug is infused.

If you are in the combination arm with nivolumab, both denikitug and nivolumab are infused during the same visit.

If you are in the chemotherapy combination arm, denikitug, ramucirumab and paclitaxel are each infused intravenously according to the schedule defined by the protocol.

Regular treatment visits

Subsequent infusions are administered at regular intervals that are defined in the study protocol; the exact frequency (for example every two or three weeks) will be explained by the study staff.

Each visit includes the infusion of the medication(s) assigned to your arm and observation for immediate reactions.

Response evaluation

At scheduled times imaging studies (such as CT scans) are performed to assess tumor size.

The measurements follow the response evaluation Criteria in solid tumours (RECIST) version 1.1, a standardized method used by investigators to determine whether the disease has responded, remained stable, or progressed.

Safety monitoring

During each visit laboratory tests are taken to monitor organ function and blood counts.

Any side effects (adverse events) you experience are recorded and graded according to the National cancer Institute common Terminology Criteria for adverse events (CTCAE) version 5.0.

The study team may adjust the treatment schedule or dosage based on safety findings.

End of treatment

Treatment may be stopped when disease progression is documented, when unacceptable side effects occur, or when the predefined number of treatment cycles is completed as specified in the protocol.

You will be informed of the reason for discontinuation.

Post‑treatment follow‑up

After the last infusion you will continue to be followed for survival and long‑term safety.

Periodic visits may include physical examinations, laboratory tests and imaging to record overall survival (OS) and any late occurring side effects.