NCT07161115: REFIRT

Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

Not yet recruiting Phase 2 Last updated 15 September 2025

What this trial tests

Phase 2 trial testing Reduced-field short-course radiotherapy in Rectal Adenocarcinoma in 60 participants. Not yet recruiting.

Timeline

19 September 2025

Primary endpoint
31 August 2028

31 August 2030

Quick facts

Lead sponsor	Longhao Li
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	19 September 2025
Primary completion	31 August 2028
Estimated completion	31 August 2030
Sites	1 location across China

Drugs / interventions tested

• Reduced-field short-course radiotherapy
• Immunotherapy combined with chemotherapy — full drug profile →
• Standard short-course radiotherapy
• Standard long-course radiotherapy
• Chemotherapy (chemotherapy) — full drug profile →

Conditions studied

• Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →

Sponsor

Longhao Li

Who can join

Adults 18 to 75, any sex, with Rectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Surgery is the primary treatment for rectal cancer. However, in patients with locally advanced disease, direct surgery often fails to achieve complete tumor resection. In such cases, neoadjuvant therapy is required to downstage the tumor before surgery. The current standard neoadjuvant approach consists of preoperative radiotherapy and then surgery. Although effective, standard radiotherapy uses large target volumes, which results in significant toxicities, increased surgical complications, and reduced patient compliance and quality of life. In addition, excessive radiation fields can compromise the intensity and timing of systemic therapy, potentially increasing the risk of distant metastasis. This may be one of the key reasons why current neoadjuvant radiotherapy mainly improves local control but has not translated into prolonged overall survival.

Emerging evidence suggests that combining immunotherapy with radiotherapy may further enhance treatment efficacy. However, large radiation fields may impair the effectiveness of immunotherapy. Therefore, reducing the radiotherapy target volume may not only decrease treatment-related toxicity but also augment the immunotherapy response.

This clinical study is designed to evaluate whether reducing the radiotherapy target volume, when combined with chemotherapy and immunotherapy prior to surgery, can decrease radiotherapy-related toxicities and reduce the risk of distant metastasis, without increasing the local recurrence rate, compared with the current standard radiotherapy fields. The ultimate goal is to improve the efficacy of neoadjuvant therapy in locally advanced rectal cancer while minimizing treatment toxicity, thereby providing new strategies and evidence for preoperative management.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.