Clinical trial NCT06853769: Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Official title: A Prospective, Single-arm, Single-center Exploratory Clinical Study of Anlotinib in Combination With Penpulimab and Conventional Chemoradiotherapy for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer

Detailed description: Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy

Chemotherapy:

Capecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.

Eligibility criteria: Inclusion Criteria:

-Patient's age: 18 years old - 80 years old -

* Rectal cancer patients diagnosed with adenocarcinoma by pathological examination of primary biopsy
* Patients with no prior treatment, preoperative clinical stage: cT3-4N+M0 rectal cancer patients (AJCC 8th);
* Patients who agree to undergo radical surgical treatment and have no contraindications to surgery as judged by the surgeon;
* No other multiple primary cancers;
* At least 1 measurable or evaluable lesion according to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST v1.1);
* Expected survival time≥ 3 months;
* A score of 0-1 based on the United States Eastern Cooperative Oncology Group Performance Status Score (ECOG PS score);
* The investigator plans to give PD-1 monoclonal antibody combined with chemotherapy treatment regimen after evaluation, and signs informed consent.

Exclusion Criteria:

* Active, known or suspected autoimmune disease;
* Known history of primary immunodeficiency;
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
* Pregnant or lactating female patients;
* Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
* Uncontrolled intercurrent illness including but not limited to:
* People living with HIV (HIV antibody positive)
* Severe infections that are active or poorly clinically controlled
* Patients with active hepatitis
* Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric, neurological, epilepsy or dementia, unstable or incompensable respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension \[i.e., greater than or equal to CTCAE grade 2 hypertension despite medication\]).
* Patients with active bleeding or new thrombotic disease, taking therapeutic dose of anticoagulant drugs or bleeding tendency, abnormal coagulation function (INR\&gt;1.5×ULN, APTT\&gt;1.5×ULN);
* Those who are currently undergoing clinical trials of other drugs;
* Other patients who are considered by the investigator to be unsuitable for inclusion.

Primary outcomes:
measure: Pathologic complete response rate（pCR）
timeFrame: assessment 2-4 weeks after surgery
Secondary outcomes:
measure: R0 resection rate
timeFrame: assessment 2-4 weeks after surgery
measure: Disease-free survival at 3 years
timeFrame: from enrollment to three years after surgery
measure: OS at 3 years
timeFrame: from enrollment to three years later
measure: RECIST1.1 Objective response rate as assessed
timeFrame: 1-2 weeks before surgery
measure: RECIST1.1 Disease control rate evaluated
timeFrame: 1-2 weeks before surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References: