Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC-nCR01)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Anlotinib hydrochloride,Penpulimab

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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>1.5×ULN, APTT>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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A; 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.

Drug: Anlotinib hydrochloride,Penpulimab; Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14; Other Names: FOCUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathologic complete response rate（pCR）	assessment 2-4 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
R0 resection rate	assessment 2-4 weeks after surgery
Disease-free survival at 3 years	from enrollment to three years after surgery
OS at 3 years	from enrollment to three years later
RECIST1.1 Objective response rate as assessed	1-2 weeks before surgery
RECIST1.1 Disease control rate evaluated	1-2 weeks before surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 2024-SR-563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No