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Safety and feasibility evaluation of short-time administration (30-minute dose) of panitumumab in combination therapy with FOLFOX for unresectable advanced or recurrent colorectal cancer: single-arm trial

A study evaluating the safety of 30-minute panitumumab infusion in combination with FOLFOX therapy for unresectable advanced or recurrent colorectal cancer

Mori Yoshinori

Nagoya City University West Medical Center　

1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi

ysmori@med.nagoya-cu.ac.jp

Mori Yoshinori

Nagoya City University West Medical Center

1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi

+81-52-991-8121

ysmori@med.nagoya-cu.ac.jp

Recruiting

Sept. 07, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients who have been histologically or cytologically diagnosed with colorectal cancer.
2. Patients with unresectable advanced or recurrent disease for whom systemic chemotherapy is indicated.
3. Patients confirmed to have wild-type RAS genes, including KRAS and NRAS.
4. Patients scheduled to newly initiate the PANI plus FOLFOX combination regimen.
5. Patients aged 20 years or older.
6. Patients with an ECOG Performance Status (PS) of 0 or 1.
7. Patients with adequate organ function who are judged by the attending physician to be able to tolerate systemic treatment.
8. Patients who have provided written informed consent to participate in this study.

1. Patients with a history of prior treatment with PANI or other anti-EGFR antibody agents.
2. Patients with hypersensitivity to PANI or any of its excipients.
3. Patients with a history of Grade 2 or higher infusion reaction (IR).
4. Patients with active pulmonary tuberculosis, poorly controlled HBV infection, or other active infections requiring treatment.
5. Patients with comorbidities, such as severe cardiovascular or respiratory disease, that are judged to make participation in the study difficult.
6. Patients confirmed to have MSI-High or dMMR disease.
7. Patients confirmed to have a BRAF V600E mutation.
8. Women who are pregnant, breastfeeding, or may be pregnant.
9. Body weight is 166 kg or more.
10. Patients who are judged by the principal investigator or a sub-investigator to be unsuitable for participation in the study for any other reason.

Both

Unresectable advanced or recurrent colorectal cancer

Patients with unresectable advanced or recurrent RAS wild-type colorectal cancer will receive panitumumab plus FOLFOX combination therapy. In this study, the intervention is intravenous infusion of panitumumab over 30 minutes. FOLFOX therapy and other supportive care will be provided in accordance with routine clinical practice. Patients will be observed for up to 5 cycles after the start of treatment, and safety and feasibility, including infusion reactions, will be evaluated.

Unresectable advanced colorectal cancer, Recurrent colorectal cancer, RAS wild-type colorectal cancer

Panitumumab, FOLFOX, 30-minute infusion, short infusion, intravenous infusion

D015179

D000077544

Incidence of Grade 3 or higher infusion reactions (IRs) occurring during short-duration PANI infusion (30-minute infusion from the second to fifth administration).

1. Incidence of Grade 3 or higher infusion reactions (IRs) occurring from the first through the fifth PANI administration.
2. Incidence of Grade 1 and Grade 2 infusion reactions (IRs) occurring during short-duration PANI infusion (30-minute infusion from the second to fifth administration).
3. Occurrence of other adverse events.
4. Completion rate of short-duration PANI infusion.
5. Patient acceptability and satisfaction with treatment.
6. Response rate.

+81-52-853-8346

July. 29, 2026

No

None