Active — Not RecruitingPhase 2

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

China20 participantsStarted 2024-01-03

Plain-language summary

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patients who were fully informed of the study and voluntarily signed the informed consent form;
✓. Patients with rectal cancers must satisfied all the following conditions:

Exclusion criteria

✕. Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
✕. Patients underwent major surgery within 4 weeks prior to study treatment;
✕. Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
✕. Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
✕. Patients who are allergic to any of the ingredients under study;
✕. Patients with severe concomitant diseases with estimated survival ≤ 5 years;
✕. Patients with present or previous moderate or severe liver and kidney damage presently or previously;
✕. Patients have received other study medications or any immunotherapy currently or in the past;

What they're measuring

CR rate

Timeframe: from preoperative to 10 days postoperative

Trial details

NCT IDNCT06056804

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Locally Advanced Rectal Cancer trials