Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer

Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07469306

Enrollment

130

Registered

2026-03-13

Start date

2026-08-10

Completion date

2027-09-01

Last updated

2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Rectal Cancer

Keywords

Modified Short-course radiotherapy (mSCRT), Long-course radiotherapy (LCRT), CAPOX, PD-1 monoclonal antibody

Brief summary

To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.

Detailed description

In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.

Interventions

RADIATIONModified Short-course radiotherapy

Rectal lesion + metastatic lymph nodes, GTV 30Gy/5Fx. Pelvic lymphatic drainage area, CTV 22.5Gy/5Fx.

RADIATIONLong-course radiotherapy

Rectal lesion + metastatic lymph nodes+pelvic lymphatic drainage area,50.4 Gy/25 f

DRUGOxaliplatin

130 mg/m²,d1, q3w ,4 cycles

DRUGCapecitabine

1000 mg/m, d1-14,bid,q3w, 4 cycles

DRUGTislelizumab

200mg,d1,q3w,4 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age 18-75 years, any gender. * Pathologically confirmed rectal adenocarcinoma. * Baseline MR stage T3-4/N+. * Distance from anal verge ≤12cm. * No distant metastasis. * Karnofsky Performance Status ≥70. * Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy. * Microsatellite/mismatch repair status MSS/pMMR. * No prior chemotherapy or any other anti-tumor treatment before inclusion. * No prior immunotherapy. * Ability to comply with the study protocol during the study period. * Signed written informed consent.

Exclusion criteria

* Pregnant or lactating women. * Pathological diagnosis of signet ring cell carcinoma. * History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ. * Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication. * Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months. * Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users. * Patients with autoimmune diseases. * Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities. * Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L. * Known deficiency of dihydropyrimidine dehydrogenase (DPD). * Allergy to any investigational drug components.

Design outcomes

Primary

Measure	Time frame	Description
Complete Response (CR) Rate	t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.	Including pCR and CCR.

Secondary

Measure	Time frame	Description
3y-LRFS	From enrollment to 36 month	Proportion of patients without local recurrence at 3 years.
3y-OS	From enrollment to 36 month	Proportion of patients alive at 3 years.
Grade ≥3 Adverse Event Rate	From start of treatment to 30 days after last dose, up to approximately 6 months	Incidence of grade 3 or higher adverse events graded according to CTCAE v4.0.
Surgical Complications	Within 30 days post-surgery	Incidence and severity of postoperative complications.
the Quality of Life	Baseline, before surgery, and up to 12 months after surgery	EORTC Core Quality of Life questionnaire (QLQ-C30)#range from 0-100, with comprehensive assessment indicators, including positive and negative indicators.
3y-DFS	From enrollment to 36 month	Proportion of patients without disease recurrence or death from any cause at 3 years.
Organ Preservation Rate	1 year.	Sphincter-saving rate in enrolled patients

Countries

China

Contacts

CONTACTJinluan Li, MD

lijinluan@fjmu.edu.cn15159628678

CONTACTChunkang Yang, MD

chunk330@163.com13509333116

PRINCIPAL_INVESTIGATORJiunluan Li, MD

Fujian Cancer Hospital

PRINCIPAL_INVESTIGATORChunkang Yang, MD