Faza II badanie kliniczne oceny odpowiedzi po radioterapii i wstrzyknięciach KRC‑01 (nadtlenek wodoru) u pacjentów z miejscowo zaawansowanym rakiem odbytnicy (stadium III)

Enrollment and baseline assessments

After joining the study, baseline data are collected, including medical history, physical Examination, imaging studies, laboratory tests, and quality‑of‑life questionnaires.

These assessments establish the initial condition before any treatment is given.

Initiation of radiotherapy

The patient begins external‑beam radiotherapy directed at the rectal tumor according to the study protocol.

Radiotherapy is delivered in fractions over several weeks; the exact schedule is defined by the trial protocol.

Administration of krc-01 injections

The investigational product krc-01 is injected directly into the tumor (intratumoral route).

Each injection contains 5 ml of a solution that includes hydrogen peroxide as the active substance.

The timing and number of injections follow the study schedule; they are performed while radiotherapy is ongoing.

Regular safety and response monitoring

Throughout treatment, the patient attends scheduled visits for clinical evaluation, blood tests, and reporting of any side effects.

Quality‑of‑life questionnaires are completed at baseline, week 6, and week 24 to document patient‑reported outcomes.

Mid‑treatment Assessment (week 6)

At week 6, a formal Assessment is performed, including imaging studies and Questionnaire completion, to evaluate early response and tolerability.

Final Assessment of clinical response (week 24)

At week 24, the primary endpoint is evaluated: the presence of a clinical complete response (cCR), meaning no detectable tumor on clinical Examination and imaging.

Additional imaging and, if indicated, pathological evaluation are performed to confirm the response.

Long‑term follow‑up

After week 24, the patient continues to be monitored for overall survival, disease progression, and any late side effects according to the study follow‑up schedule.

Periodic assessments may include imaging, laboratory tests, and quality‑of‑life questionnaires.