Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab

Phase 2

Not yet recruiting

• Conditions: Rectal Cancer
• Interventions: Drug: Camrelizumab; Drug: Chemotherapy; Radiation: Radiotherapy

• Registration Number: NCT06304545
• Lead Sponsor: Harbin Medical University

Brief Summary

This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation.

Detailed Description

This study plans to recruit 48 patients with locally advanced/low anal preservation requiring rectal cancer. The study aims to observe and evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-10
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Study Start: 2024-03-15
• Primary Completion: 2026-08-16
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Age: 18 to 75 years old, male or female,
2. Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria),
3. Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (<5 cm from anal verge; T2N0M0),
4. Expected survival > 3 months,
5. ECOG PS score: 0-1,
6. No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed,
7. No previous radiotherapy or immune checkpoint inhibitor treatment for rectal cancer,
8. Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during screening):

1)Absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 80 x 10^9/L; hemoglobin ≥ 8.5 g/dL, 2)Thyroid-stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled), 3)Bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN, 4) Serum creatinine ≤1.5 times ULN, 9. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose, 10. Subjects voluntarily enrolled in the study and signed an informed consent form.

Exclusion Criteria

1. Previous pelvic or abdominal radiotherapy,
2. Tumours that are expected to be unresectable after neoadjuvant therapy,
3. Pregnant or lactating women, or those of childbearing potential who refuse to use contraception,
4. History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled,
5. Ineffectively controlled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction,
6. Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function,
7. Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment,
8. Congestive heart failure, difficult-to-control cardiac arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient is chaemic attack, severe hypertension difficult to control with medication, or other patients who cannot tolerate the procedure,
9. Severe active infections requiring intravenous antibiotic treatment occurring during the screening period,
10. Allergy to the test drug,
11. Have received or will receive a live vaccine within 30 days prior to camrelizumab administration,
12. Known history of HIV infection or active hepatitis B or C,
13. Patients who are unable to comply with the trial protocol or are unable to cooperate with follow-up visits,
14. Those who in the opinion of the investigator are not suitable for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy combined with immunotherapy for early rectal cancer.	Camrelizumab	Radiotherapy and Chemotherapy combined with Camrelizumab
Chemoradiotherapy combined with immunotherapy for early rectal cancer.	Chemotherapy	Radiotherapy and Chemotherapy combined with Camrelizumab
Chemoradiotherapy combined with immunotherapy for early rectal cancer.	Radiotherapy	Radiotherapy and Chemotherapy combined with Camrelizumab

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response rate	up to 24 months	After neoadjuvant therapy and surgery, postoperative specimens showed no residual surviving tumor cells in the tumor bed (%RVT=0).

Secondary Outcome Measures

Name	Time	Method
3-years Overall Survival rate	up to 36 months	Proportion of death from randomization to 3 years of treatment.
Disease Control Rate	up to 24 months	Determined using RECIST v1.1 criteria.
Disease-free Survival	up to 24 months	The time from surgical resection to the first tumor recurrence and metastasis, or the patient's death due to any reason.
Objective Response Rate	up to 24 months	Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
AEs	up to 24 months	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Anal preservation rate	up to 24 months	Proportion of patients with low rectal cancer who retain their anus after surgery.
Overall Survival	up to 36 months	Defined as the time from randomizstion to death from any cause.