Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer

Conditions

• Rectal Cancer Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Short-Course Radiotherapy — RADIATION
  Short-course radiotherapy is a radiation therapy regimen delivered over a condensed period. In this study, patients will receive a total dose of 25 Gray (Gy), administered in 5 fractions (5 Gy per fraction), delivered once daily over five consecutive days. This intervention constitutes the initial phase of the neoadjuvant treatment protocol.
• Liposomal Irinotecan (nal-IRI) — DRUG
  Liposomal irinotecan is a nanoliposomal formulation of the chemotherapeutic agent irinotecan, designed to enhance tumor drug delivery and reduce systemic toxicity. In this study, it will be administered intravenously at a dose of 60 mg/m² on Day 1 of each 21-day cycle, for a total of 8 cycles, following the completion of short-course radiotherapy.
• Capecitabine — DRUG
  Capecitabine is an oral fluoropyrimidine carbamate prodrug that is converted to 5-fluorouracil in the body. In this study, it will be administered orally at a dose of 1000 mg/m² twice daily (BID) from Days 1 to 14 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and camrelizumab.
• Camrelizumab — DRUG
  Camrelizumab is a humanized monoclonal antibody that targets the programmed cell death-1 (PD-1) receptor on immune cells, functioning as an immune checkpoint inhibitor. In this study, it will be administered intravenously at a fixed dose of 200 mg on Day 1 of each 21-day cycle, for a total of 8 cycles, in combination with liposomal irinotecan and capecitabine.

Study Details

This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum. The main things you will do in this study are: 1. Receive a Short Course of Radiation Therapy (5 treatments over 1 week). 2. After a 1-week break, receive a combination of three drugs: 1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded. The most important goal of this research is to see how many patients achieve a "Complete Response," which means: 1. No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or 2. No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a "Watch and Wait" strategy (Clinical Complete Response, cCR). Researchers will also monitor: 1. The safety of the treatment and its side effects. 2. How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence). 3. The rate of successful tumor removal and the rate of preserving the anus.

Key Dates

Start date

May 20, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2031

Completion

Dec 31, 2034

Study Design

Enrollment

44 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Neoadjuvant Therapy Arm

Primary Outcome Measure

Complete Response Rate [ Time Frame: From the start of treatment until approximately 2 weeks after the completion of all neoadjuvant therapy, assessed over a period of approximately 24-26 weeks. ]

Central Contacts

• Deqing Wu, Dr.
  020 83827812 60910
  [email protected]