Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT06853769 | Active Not Recruiting Early Phase 1

• 1 other identifier: 2024-SR-563
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate（pCR）

  assessment 2-4 weeks after surgery

Secondary Outcomes (5)

• 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

Study Arms (1)

Arm A

EXPERIMENTAL

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

Interventions

Anlotinib hydrochloride,Penpulimab DRUG

Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14

Also known as: FOCUS

Arm A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

penpulimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: March 3, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)